*

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-08-04 for * manufactured by *.

Event Text Entries

[490287] Status post d&e, the tenaculum site was noted to be bleeding, a continuous running suture was placed in the anterior lip of the cervix to control bleeding.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 745132
• MDR Report Key: 745132
• Date Received: 2006-08-04
• Date of Report: 2006-08-03
• Date of Event: 2006-06-30
• Date Facility Aware: 2006-06-30
• Report Date: 2006-08-03
• Date Reported to FDA: 2006-08-03
• Date Added to Maude: 2006-08-09
• 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
• 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: *
• Generic Name: TENACULUM
• Product Code: HDC
• Date Received: 2006-08-04
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: UNKNOWN
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 732920
• Manufacturer: *
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2006-08-04