BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UPHOLD VAGINAL SUPPORT SYSTEM

    MDR report key: 3072833 · Received April 23, 2013

    Report

    Report Number
    3005099803-2013-03067
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    March 28, 2013
    Report Date
    March 28, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K081048
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THE REPORTED LOT NUMBER, M00000830, COULD NOT BE VERIFIED. CONSEQUENTLY, THE MANUFACTURE AND EXPIRATION DATES CANNOT BE DETERMINED. 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 A UTERINE PROLAPSE REPAIR PROCEDURE USING AN UPHOLD VAGINAL SUPPORT SYSTEM, THE CAPIO NEEDLE CARRIER BECAME BENT AND GOT STUCK INSIDE THE CAGE WHERE IT DETACHED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING A UTERINE PROLAPSE REPAIR PROCEDURE USING AN UPHOLD VAGINAL SUPPORT SYSTEM, THE CAPIO NEEDLE CARRIER BECAME BENT AND GOT STUCK INSIDE THE CAGE WHERE IT DETACHED. 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
    175665 UPHOLD VAGINAL SUPPORT SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH M0068317080 ML00000830

    Patients

    Seq Age Sex Outcome Treatment
    1