BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UPHOLD VAGINAL SUPPORT SYSTEM

    MDR report key: 3122910 · Received May 21, 2013

    Report

    Report Number
    3005099803-2013-03845
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    April 25, 2013
    Report Date
    April 26, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K081048
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6)

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING A PROLAPSE REPAIR PROCEDURE USING AN UPHOLD VAGINAL SUPPORT SYSTEM, THE PHYSICIAN ENCOUNTERED DIFFICULTY PLACING THE FIRST LEG ASSEMBLY THROUGH TISSUE. WHEN THE CAPIO DEVICE WAS INSPECTED, THE PHYSICIAN NOTICED THAT THE CARRIER WAS BENT, PREVENTING THE PLACEMENT OF THIS LEG ASSEMBLY FROM OCCURRING. WHEN THE PHYSICIAN ATTEMPTED TO MANUALLY STRAIGHTEN THE BENT CARRIER OUTSIDE THE PATIENT, THE CARRIER DETACHED FROM THE CAPIO DEVICE. THE PHYSICIAN COMPLETED THE PROCEDURE WITH ANOTHER UPHOLD VAGINAL SUPPORT SYSTEM. THERE WERE NO COMPLICATIONS TO THE PATIENT, WHO IS OVER 18 YEARS OF AGE AND WAS STABLE AT THE CONCLUSION OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224949 UPHOLD VAGINAL SUPPORT SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH M0068317080 ML00001315

    Patients

    Seq Age Sex Outcome Treatment
    1