FDA Adverse Event Injury Summary report: N

BARD SOFT MESH

MDR report key: 3070373 · Received April 16, 2013

Report

Report Number
MW5029840
Event Type
Injury
Date Received
April 16, 2013
Date of Event
March 9, 2011
Report Date
April 16, 2013
Manufacturer
BARD
Product Code
FTL
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
ID, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

I WENT IN FOR A PARTIAL HYSTERECTOMY. MY OB RECOMMENDED THAT I GET A BLADDER SLING SINCE I HAD 3 CHILDREN AND "WOULD EVENTUALLY NEED ONE ANYWAY." I AGREED. I HAD A BARD SOFT MESH REF 0117009, LOT HUUJ0800 3"X6" INSERTED. APPROXIMATELY ONE YEAR AFTER MY OPERATION I BEGAN SUFFERING FROM CHRONIC BLADDER INFECTIONS AND SEVERE PAIN DURING INTERCOURSE. APPROXIMATELY THE SAME TIME MY HUSBAND BEGAN GETTING EXTREMELY SORE AS WELL. WE INCREASED LUBRICANT BUT IT CONTINUED TO BE PAINFUL. APPROXIMATELY 6 MONTHS AGO THE INFECTIONS AND PAIN BECAME INTOLERABLE AND IT BEGAN SEVERELY IMPACTING MY ABILITY TO FUNCTION. ONE DAY MY HUSBAND COMMENTED THAT THE SENSATION DURING INTERCOURSE WAS MUCH LIKE SANDPAPER. WHEN HE MADE THAT COMMENT I DECIDED I SHOULD GO TO MY OB. WHEN I WAS EXAMINED BY MY OB HE INDICATED THAT MY SLING HAD ERODED AND IT WOULD NEED TO BE REPAIRED. DUE TO FINANCIAL CONSTRAINTS HE INDICATED THAT HE COULD PROBABLY REPAIR IT IN HIS OFFICE INSTEAD OF GOING BACK INTO THE HOSPITAL. I AGREED. HE WAS ABLE TO REPAIR THE EROSION, CLIPPED THE WORN AREA, PULLED SKIN OVER THE EXPOSED AREA AND STITCHED THE SKIN TOGETHER. I UNDERSTAND THIS SPECIFIC SLING HAS NOT BEEN RECALLED, BUT I WANTED TO REPORT THAT MINE ONLY LASTED ABOUT ONE YEAR BEFORE IT BEGAN ERODING. I WANTED MY OB TO COMPLETELY REMOVE IT BECAUSE I DON'T EVER WANT TO LIVE THROUGH THAT KIND OF PAIN AGAIN BUT HE SAID THERE IS TOO MUCH OF A RISK WHEN REMOVING THEM SO HE WANTED TO BEGIN WITH THE LESS EVASIVE PROCEDURE FIRST. THAT DOESN'T MAKE ME VERY COMFORTABLE; ESPECIALLY SINCE I DIDN'T NEED IT TO BEGIN WITH. I JUST AGREED BECAUSE IT SOUNDED LIKE A ROUTINE PROCEDURE, KIND OF LIKE WHEN TAKING OUT TONSILS THEY REMOVE THE ADENOIDS. I JUST DON'T WANT OTHER WOMEN TO MAKE THE SAME MISTAKE I DID.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
163327 BARD SOFT MESH BLADDER SLING FTL BARD HUUJ0800

Patients

Seq Age Sex Outcome Treatment
1 47 YR Other| R