BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UPHOLD VAGINAL SUPPORT SYSTEM

    MDR report key: 2914746 · Received January 15, 2013

    Report

    Report Number
    3005099803-2013-00246
    Event Type
    Injury
    Date Received
    January 15, 2013
    Date of Event
    December 19, 2012
    Report Date
    December 19, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K081048
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINANT INDICATED THAT THE DEVICE WAS NOT USED PAST ITS EXPIRY DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING AN ANTERIOR REPAIR PROCEDURE USING AN UPHOLD VAGINAL SUPPORT SYSTEM, AS THE PHYSICIAN WAS PULLING THE LEG ASSEMBLY THROUGH TISSUE, THE NEEDLE DETACHED INSIDE THE PATIENT.THE PHYSICIAN WAS UNABLE TO LOCATE THE NEEDLE BY PALPATION OR X-RAY TO REMOVE IT, SO IT WAS LEFT INSIDE THE PATIENT. THE PHYSICIAN WAS ABLE TO COMPLETE THE PROCEDURE WITH THIS 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
    23160 UPHOLD VAGINAL SUPPORT SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH M0068317080

    Patients

    Seq Age Sex Outcome Treatment
    1 Other