FDA Adverse Event Injury Summary report: N

TVT DEVICE 810041 C1771

MDR report key: 1609495 · Received February 15, 2010

Report

Report Number
MW5014781
Event Type
Injury
Date Received
February 15, 2010
Report Date
February 15, 2010
Manufacturer
UNKNOWN
Product Code
FTL
Report Source
Voluntary report
Reporter Location
IL, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

ON (B) (6) 2001, TVT SLING / TAPE IMPLANT. I UNDERWENT URETHRAL SLING PROCEDURE SEVERAL YEARS AGO. ON (B) (6) 2009, PRE-OP DIAGNOSIS MIXED URINARY INCONTINENCE, RULE OUT VAGINAL MESH EROSION. POST -OP DIAGNOSIS URETHRAL EROSION. I HAD NOTED RECURRENT SYMPTOMS WITH MIXED URINARY INCONTINENCE INCLUDING STRESS, URGE AS WELL AS INCONTINENCE WITHOUT WARNING. HISTORY OF CONSTANT SIGNIFICANT VAGINAL PAIN. THERE WAS A LARGE DEFECT IN THE VAGINAL WALL WHERE THERE WAS A SIGNIFICANT EROSION INTO THE URETHRAL. THE VAGINAL EPITHELIUM AROUND THIS EROSION WAS CHRONICALLY INFLAMED AND VERY FRIABLE. THE VISUAL INSPECTION OF THE BLADDER DEMONSTRATED AS LEAST MODERATE DESCENT OF THE BLADDER CONSISTENT WITH CYSTOCELE. THERE WAS SOME LOSS OF COAPTATION OF THE PROXIMAL URETHRA IN THE BLADDER NECK. GIVEN THE SIGNIFICANT FRIABILITY AND THE LARGE DEFECT COMPLEX, MOBILIZATION OF THE URETHRA WAS PERFORMED. DATES OF USE: (B) (6) 2001 -- (B) (6) 2009. DIAGNOSIS OR REASON FOR USE: URINARY INCONTINENCE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 TVT DEVICE 810041 C1771 TVT DEVICE 810041 C1771 FTL UNKNOWN 889488

Patients

Seq Age Sex Outcome Treatment
1 45 YR Hospitalization| O| R| S