- MedSun Adverse Events Reports
- MD Medical Product Safety Network
- Medical Devices Safety Network
- Medical Product Safety
- Adverse Event Reporting Program
- MD Safety
- MD Reporting
Medical Product Safety Network
The Medical Product Safety Network (MedSun) is an adverse event reporting program launched by the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH).
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The Medical Product Safety Network dataset involves the reporting of problems with medical products from a network of approximately 300 hospitals, nursing homes and home health facilities around the United States.
MedSun sites work collaboratively with the FDA to assist in detecting, understanding, and sharing information concerning the safety of medical products. MedSun utilizes a secure, online system for reporting problems with the use of medical devices. MedSun plays a critical role in FDA’s postmarket surveillance efforts.
The primary goal for MedSun is to work collaboratively with the clinical community to identify, understand, and solve problems with the use of medical devices.
The Safe Medical Devices Act (SMDA) defines ‘user facilities’ as hospitals, nursing homes, and outpatient treatment and diagnostic centers. They are required to report medical device problems that result in serious illness, injury, or death. MedSun participants are also highly encouraged to voluntarily report problems with devices, such as ‘close-calls,’ potential for harm, and other safety concerns. By monitoring reports about problems and concerns before a more serious event occurs, FDA, manufacturers, and clinicians work together proactively to prevent serious injuries and death.
About this Dataset
2006-03-24 to 2022-07-27
John Snow Labs; U.S. Food and Drug Administration (FDA);
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Medical Product Safety, Adverse Event Reporting Program, MedSun, MD Safety, MD Reporting
MedSun Adverse Events Reports, MD Medical Product Safety Network, Medical Devices Safety Network
|Device_Brand||The brand of medical device||string||-|
|Device_Manufacturer||Device manufacturer name||string||-|
|Device_Type||The type of medical device||string||-|
|Device_Problem||Problem associated with the device||string||-|
|Date_Report||The Date report||date||required : 1|
|Event_Description||The Event description||string||-|
|Device Brand||Device Manufacturer||Device Type||Device Problem||Date Report||Event Description|
|Safe-T||CAREFUSION 2200 INC||Lumbar puncture tray (adult & pediatric)||Minor injury to the patient or health care provider||2023-01-23||Foam needle stop was not adhered to the bottom of the tray - so it came out when needle was placed in it. 22-gauge needles in use. Staff member put the plastic cap flat on the tray and slid the needle in. She moved the needle vertically to secure the cap and the cap poked through the top of the plastic cap. Employee needlestick injury occurred. Two prior incidents with this lot did not result in employee injury. ====================== Manufacturer response for Lumbar puncture tray (adult pediatric) - Safe-T (per site reporter) ====================== I will be forwarding this on to our field assurance team. Even though we are no longer selling this item - we do indeed need to be made of any adverse events. Thank you.|
|RD SET||MASIMO CORPORATION||Oximeter||Minor injury to the patient or health care provider||2023-01-20||Injury to patient - burn found under pulse ox on R lateral foot|
|RD SET||MASIMO CORPORATION||Oximeter||Minor injury to the patient or health care provider||2023-01-20||Parents pointed out to this RN that infant had received a wound on a previous shift from the pulse ox probe. This RN noted there was a red mark on the top of the infant's foot that was in the same location the pulse ox probe would lie.|
|RD SET||MASIMO CORPORATION||Oximeter||Minor injury to the patient or health care provider||2023-01-20||While completing the morning skin integrity assessment on this patient - the nurse removed the pulse oximeter from his right foot and underneath it was an approximately 1 cm x 0.5 cm burn/abrasion/reddened area. While the skin is intact - the reddened area looks similar to a burn and is dark red.|
|RD SET||MASIMO CORPORATION||Oximeter||Minor injury to the patient or health care provider||2023-01-20||Intact blister found on foot while moving the pulse oximeter probe to the opposite foot during initial assessment. The pulse oximeter probe was over the site where the blister was found.|
|RD SET NeoPt-500 SpO2 PR PI PVI Neonatal Pulse Oximeter Non-Adhesive Sensor||MASIMO CORPORATION||Oximeter||Minor injury to the patient or health care provider||2023-01-20||Infant was noted to have a burn on his R foot where pulse ox had been in place.|
|RD SET||MASIMO CORPORATION||Oximeter||Minor injury to the patient or health care provider||2023-01-20||Injury same shape as red light on pulse oxy probe. perfectly oval. Burn/ pressure sore.|
|RD SET||MASIMO CORPORATION||Oximeter||Minor injury to the patient or health care provider||2023-01-20||Upon removal of pulse oximeter from left foot to place onto left hand -a small reddened area was noted to lateral/plantar surface of foot. Upon further inspection - noted that right foot also had similar reddened areas to both the medial & lateral plantar surface of foot. Notified neonatologist and had her evaluate. Discussed with Charge Nurse. After discussion w/MD - planned to change out pulse oximeter fastener to soft foam - from sticky brown/bandage type fastener that was previously present. Upon taking the pulse oximeter off of the left hand (where it was briefly placed before changing it out completely - an indentation was noted on the left palmar surface of the hand - consistent w/a protrusion noted in the plastic in the center of the pulse oximeter probe. Upon closer inspection of old pulse ox probe it was noted that the center of the pulse ox probe had molded into a small firm line - which created a protrusion that seemed to mimic the sizing of the wounds on the feet. At that time - decided to get a brand new pulse oximeter w/soft foam fastener.|
|Stryker||STRYKER CORPORATION||Electrosurgical Cutting & Coagulation & Accessories||Potential harm to a health care provider||2023-01-20||Started cesarean surgical case - device seemed to be working normally. Once the Coag button was used - the device got stuck in Coag mode - constant beep heard from machine. Unable to get it to turn off. Device was unplugged - and when plugged back in - an error message showed up on the screen with a caution triangle that said something to the effect of replace device. Unit was replaced with a new pencil which worked appropriately.|
|RD SET||MASIMO CORPORATION||Oximeter||Minor injury to the patient or health care provider||2023-01-20||Upon changing pulse ox probe site - this RN noticed reddened open areas on both the top and bottom of the foot (area that pulse ox probe was in contact with) were reddened are open.|