UNK *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-05-16 for UNK * manufactured by Unk.

Event Text Entries

[51849] During laparoscopic bilateral tubal fulguration, the tenaculum tore through the cervix. The cervix required repair by suturing. Surgical short procedure pt; discharged same day.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 91956
• MDR Report Key: 91956
• Date Received: 1997-05-16
• Date of Report: 1997-05-14
• Date of Event: 1997-05-08
• Date Facility Aware: 1997-05-12
• Report Date: 1997-05-14
• Date Reported to FDA: 1997-05-14
• Date Added to Maude: 1997-05-21
• 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
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• 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: UNK
• Generic Name: TENACULUM
• Product Code: HDC
• Date Received: 1997-05-16
• Model Number: UNK
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: UNKNOWN
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 90833
• Manufacturer: UNK
• Manufacturer Address: UNK UNK *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1997-05-16