BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLADDER SLING

    MDR report key: 4251441 · Received November 4, 2014

    Report

    Report Number
    MW5039030
    Event Type
    Injury
    Date Received
    November 4, 2014
    Date of Event
    November 22, 2011
    Report Date
    November 4, 2014
    Product Code
    PAH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I WAS TREATED WITH BLADDER SLING AND ALSO WITH A HERNIA MESH BY THE SAME DOCTOR AT THE SAME (B)(6) HOSPITAL IN (B)(6). NOW LAST YEAR, AFTER I WAS GOING BACK AND FORTH INTO THE HOSPITAL, THEY SAID IT WAS SCARRING AND FROM THE DEVICE. BUT NO, ONE WANTS TO REMOVE IT, WHY I DON'T KNOW. IS THIS HOW I AM GOING TO DIE CRYING FOR HELP TO GET THESE THINGS OUT OF ME. NOW THE HERNIA PAIN HAS GOTTEN SO BAD THAT IT FEELS LIKE SOMEONE IS SITTING ON MY BLADDER AND FOR THE HERNIA IT'S PULLING ON MY STOMACH AND GROIN AREA. THE HOSPITAL IS STILL IMPLANTING PEOPLE WITH THESE DEVICES. FDA NEEDS TO STOP THEM AND FILE A CLASS ACTION ON NOT FOLLOWING GUIDELINES AFTER FDA SAYS STOP. ONE SURGERY WAS HERNIA REPAIR ON (B)(6) 2012 BLADDER SLING WAS (B)(6) 2013 AFTER THIS I WAS NOT THE SAME. ON (B)(6) 2012 OTHER (B)(6) 2013. I AM NOT SEXUALLY ACTIVE BUT IN PAIN DOWN BELOW. DATES OF USE: (B)(6) 2012 - (B)(6) 2013. DIAGNOSIS OR REASON FOR USE: HERNIA REPAIR MESH; BOWEL/MESH PROLAPSE. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED?: NO. EVENT REAPPEARED AFTER REINTRODUCTION? YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706719 BLADDER SLING BLADDER SLING PAH
    706845 MESH MESH FTL

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| L| O| S