HEMOSTAT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-04-03 for HEMOSTAT manufactured by Lawton Stainless.

Event Text Entries

[824] During surgery a portion of the hemostat was broken off and remained in patient's foot. Removed same day. Confirmed by x-raydevice 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. No 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, visual examination. Results of evaluation: invalid data, invalid data. Conclusion: device failure occurred and was related to event, device failure directly caused event. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: device permanently removed from service, invalid data. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 496
• MDR Report Key: 496
• Date Received: 1992-04-03
• Date of Report: 1992-03-27
• Date of Event: 1992-03-18
• Date Facility Aware: 1992-03-18
• Report Date: 1992-03-27
• Date Reported to FDA: 1992-03-27
• Date Added to Maude: 1992-05-05
• 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

• Generic Name: HEMOSTAT
• Product Code: EMD
• Date Received: 1992-04-03
• Lot Number: N/A
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Implant Flag: *
• Device Sequence No: 1
• Device Event Key: 489
• Manufacturer: LAWTON STAINLESS

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1992-04-03