UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-08-10 for UNK manufactured by Unk.

Event Text Entries

[329419] During a d&c, hysteroscopy, a laceration of the cervix was sustained during dilatation of the cervix with the tenaculum. The cervix required suturing.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 539126
• MDR Report Key: 539126
• Date Received: 2004-08-10
• Date of Report: 2004-08-02
• Date of Event: 2004-07-27
• Date Facility Aware: 2004-07-30
• Report Date: 2004-08-02
• Date Reported to FDA: 2004-08-02
• Date Added to Maude: 2004-08-17
• 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: 3
• 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: 2004-08-10
• Model Number: UNK
• Catalog Number: UNK
• Lot Number: UNK
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: UNKNOWN
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 528421
• Manufacturer: UNK
• Manufacturer Address: UNK UNK *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2004-08-10