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 Number: 7706
• MDR Report Key: 7706
• Date Received: 1994-01-03
• Date of Report: 1993-11-24
• Date of Event: 1993-11-11
• Date Facility Aware: 1993-11-11
• Report Date: 1993-11-24
• Date Reported to Mfgr: 1993-11-22
• Date Added to Maude: 1994-05-10
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 0
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ZIMMER
• Generic Name: TOURNIQUET CUFF 42 INCH
• Product Code: DRP
• Date Received: 1994-01-03
• Catalog Number: 60-2591-001
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 7385
• Manufacturer: ZIMMER

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1994-01-03