ZIMMER 60-2591-001

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-01-03 for ZIMMER 60-2591-001 manufactured by Zimmer.

Event Text Entries

[22075387] Tourniquet applied per physician. Tourniquet set a 450. At end of case a bruise noted the size of half dollar on (r) inner thigh plus discoloration noted along tourniquet site. Device not labeled for single use. Patient medical status prior to event: satisfactory condition. There was not 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. Imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, mechanical tests performed, visual examination. Results of evaluation: component failure, telemetry failure. Conclusion: device failure occurred and was related to event, device failure directly caused event. Certainty of device as cause of or contributor to event: yes. Corrective actions: device temporarily removed from service. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number7706
MDR Report Key7706
Date Received1994-01-03
Date of Report1993-11-24
Date of Event1993-11-11
Date Facility Aware1993-11-11
Report Date1993-11-24
Date Reported to Mfgr1993-11-22
Date Added to Maude1994-05-10
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 NameZIMMER
Generic NameTOURNIQUET CUFF 42 INCH
Product CodeDRP
Date Received1994-01-03
Catalog Number60-2591-001
OperatorOTHER HEALTH CARE PROFESSIONAL
Device AvailabilityY
Implant FlagN
Device Sequence No1
Device Event Key7385
ManufacturerZIMMER


Patients

Patient NumberTreatmentOutcomeDate
101. Other 1994-01-03

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