BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANTERIOR/POSTERIOR ELEVATE MESH

    MDR report key: 3140844 · Received May 24, 2013

    Report

    Report Number
    MW5030335
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    December 28, 2009
    Report Date
    May 24, 2013
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD A TENSION-FREE-OBTURATOR TAPE SLING FOR INCONTINENCE, ANTERIOR ELEVATE MESH SYSTEM FOR ANTERIOR REPAIR, POSTERIOR ELEVATE MESH SYSTEM FOR RECTOCELE REPAIR, POSTERIOR ELEVATE MESH SYSTEM FOR VAGINAL VAULT SUSPENSION. PATIENT FOLLOWED INSTRUCTIONS OF ATTENDING PHYSICIAN FOR RECOVERY AND CARE AFTER SURGERY. HOWEVER, ABOUT A YEAR AFTER PROCEDURE PATIENT STARTED TO GET PAIN IN LOWER PELVIC AREA AND PAIN WITH INTERCOURSE. SHE INFORMED HER PHYSICIAN WHO CHECKED TO MAKE SURE SHE WAS USING THE ESTRAGEN CREAM AND SHE WAS. PATIENT WAS NOT SATISFIED WITH HER CARE AND DESIRED A SECOND OPINION. SO SHE CAME TO SEE ME AND ON EXAM SHE HAD SOME MESH THAT HAD ERODED INTO THE VAGINAL WALL. REASON FOR USE: INCONTINENCE, VAGINAL PROLAPSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232343 ANTERIOR/POSTERIOR ELEVATE MESH VAULT SUSPENSION MESH FTL

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Disability