BOOK WALTER RETRACTOR * 50-4591

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-12-06 for BOOK WALTER RETRACTOR * 50-4591 manufactured by Codman.

Event Text Entries

[21381265] Vaginal tear at 4 o'clock after removing retractor. Approx 1-1 1/2 repaired. No further bleeding.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number	253122
MDR Report Key	253122
Date Received	1999-12-06
Date of Report	1999-11-15
Date of Event	1999-11-10
Date Facility Aware	1999-11-10
Report Date	1999-11-15
Date Reported to Mfgr	1999-11-15
Date Added to Maude	1999-12-13
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	BOOK WALTER RETRACTOR
Generic Name	VAGINAL RETRACTOR
Product Code	HDL
Date Received	1999-12-06
Model Number	*
Catalog Number	50-4591
Lot Number	*
ID Number	*
Operator	HEALTH PROFESSIONAL
Device Availability	Y
Device Age	1 DAY
Implant Flag	N
Date Removed	A
Device Sequence No	1
Device Event Key	245089
Manufacturer	CODMAN
Manufacturer Address	325 PARAMOUNT DR. RAYNHAM MA 02767 US
Baseline Brand Name	MAGRINA BOOKWALTER VAGINAL RETRACTOR
Baseline Generic Name	RETRACTOR, VAGINAL
Baseline Model No	NA
Baseline Catalog No	50-4591
Baseline ID	NA
Baseline Device Family	MAGRINA BOOKWALTER VAGINAL 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	1999-12-06