UNK *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-05-20 for UNK * manufactured by Unk.

Event Text Entries

[135177] When vaginal speculum removed at end of "leep" procedure, a laceration of the vagina was noted. Suture repair completed. Pt without problems per follow-up 05/13/1998.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 168983
• MDR Report Key: 168983
• Date Received: 1998-05-20
• Date of Report: 1998-05-15
• Date of Event: 1998-05-12
• Date Facility Aware: 1998-05-12
• Report Date: 1998-05-15
• Date Reported to FDA: 1998-05-14
• Date Added to Maude: 1998-05-28
• 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: VAGINAL SPECULUM
• Product Code: HDF
• Date Received: 1998-05-20
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: NO IDENTIFIERS
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: UNKNOWN
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 164374
• Manufacturer: UNK
• Manufacturer Address: UNK UNK *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1998-05-20