FDA Adverse Event Injury Summary report: N

DO NOT KNOW

MDR report key: 2202043 · Received August 7, 2011

Report

Report Number
MW5021667
Event Type
Injury
Date Received
August 7, 2011
Date of Event
August 4, 2011
Report Date
August 7, 2011
Manufacturer
DO NOT KNOW
Product Code
FTL
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
MN, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

MESH WAS IMPLANTED FOR PELVIC ORGAN PROLAPSE AND URINARY INCONTINENCE IN 2008. I EXPERIENCED PAIN, BLADDER INFECTIONS, AND BLOOD IN THE URINE. I RETURNED TO MY DOCTOR, WHO LOOKED FOR EXTRUSION OF THE MESH INTO MY VAGINA, BUT FAILED TO DO A CYSTOSCOPY TO CHECK FOR EROSION INTO THE URETHRA AND BLADDER. HE SENT ME HOME, SAYING HE COULD CUT THE MESH, BUT I WOULD BE INCONTINENT; OR I COULD PUT UP WITH THE PAIN. NOW, THREE YEARS LATER, WITH FRANK BLOOD IN MY URINE, I WENT TO A UROLOGIST WHO FOUND THAT THE MESH HAD SAWED ABOUT THREE-QUARTERS OF THE WAY THROUGH MY URETHRA. SHE RECOMMENDED IMMEDIATE SURGERY TO REMOVE THE MESH AND RECONSTRUCT THE URETHRA; THIS WAS DONE THREE DAYS AGO. I WILL BE OUT OF WORK FOR THREE WEEKS, AT HOME WITH AN INDWELLING CATHETER; AND MY URETHRA IS PERMANENTLY SCARRED. I WILL ALWAYS HAVE TO CAREFULLY MONITOR MY ABILITY TO FULLY EMPTY MY BLADDER AND POSSIBLY HAVE RECURRENT PAINFUL PROCEDURES TO KEEP MY URETHRA OPEN, FOR THE REST OF MY LIFE. I AM (B)(6) AND VERY ACTIVE. PRODUCT USE ERROR: MESH INSTALLED IMPROPERLY, OR MESH AN UNSAFE COMPONENT OF A URETHRAL SLING. PHYSICIANS NEED TO BE WARNED: CHECK PATIENTS COMPLAINING OF PAIN WITH CYSTOSCOPE; REPEAT LATER IF PAIN CONTINUES. DO NOT IGNORE URETHRAL OR VAGINAL PAIN IN A PATIENT WITH THIS HISTORY. CHECK URINALYSIS FOR HEMATURIA (BLOOD IN URINE).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 DO NOT KNOW TRANSVAGINAL MESH FTL DO NOT KNOW

Patients

Seq Age Sex Outcome Treatment
1 47 YR Disability