DEFIB-PAD 2345N, 34-7032-5668-4

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-03-08 for DEFIB-PAD 2345N, 34-7032-5668-4 manufactured by 3m Health Care.

Event Text Entries

[9499] Debif pad three times in one month patient burned when defibrillated; withdrew product. Product problem reproted to above manufacturer and report submitted to fda. Invalid data - regarding single use labeling of device. Patient medical status prior to event: invalid data. Invalid data - regarding multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. Invalid data - regarding whether event presents imminent hazard. Invalid data - whether device used as labeled/intended. Invalid data - regarding evaluation by user after event. Method of evaluation: invalid data. Results of evaluation: invalid data. Conclusion: invalid data. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: no data. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number10020
MDR Report Key10020
Date Received1994-03-08
Date of Report1993-10-12
Report Date1993-10-12
Date Added to Maude1995-03-17
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameDEFIB-PAD
Product CodeDRK
Date Received1994-03-08
Model Number2345N, 34-7032-5668-4
Device Availability*
Implant Flag*
Device Sequence No1
Device Event Key9672
Manufacturer3M HEALTH CARE


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 1994-03-08

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.