* NONE F410

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-01-23 for * NONE F410 manufactured by Coopersurgical, Inc..

Event Text Entries

[589882] At completion of leep procedure bilateral vaginal sidewall burns noted along path of vaginal sidewall retractor.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 820034
• MDR Report Key: 820034
• Date Received: 2007-01-23
• Date of Report: 2006-08-16
• Date of Event: 2006-08-15
• Date Facility Aware: 2006-08-15
• Report Date: 2006-08-16
• Date Reported to Mfgr: 2006-08-16
• Date Added to Maude: 2007-02-27
• 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: *
• Generic Name: LATERAL VAGINAL LEEP RETRACTOR
• Product Code: HDL
• Date Received: 2007-01-23
• Model Number: NONE
• Catalog Number: F410
• Lot Number: NONE
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 807514
• Manufacturer: COOPERSURGICAL, INC.
• Manufacturer Address: 95 CORPORATE DR. TRUMBULL CT 06611 US
• Baseline Brand Name: LEEP
• Baseline Generic Name: LATERAL WALL RETRACTOR
• Baseline Model No: F410
• Baseline Catalog No: F410
• Baseline ID: F420
• Baseline Device Family: CER-VIEW LATERAL WALL RETRACTOR
• Baseline Shelf Life [Months]: NA
• Baseline PMA Flag: N
• Baseline 510K PMN: N
• Baseline Preamendment: N
• Baseline Transitional: N
• 510k Exempt: Y

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2007-01-23