BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UPHOLD VAGINAL SUPPORT SYSTEM

    MDR report key: 2052289 · Received April 12, 2011

    Report

    Report Number
    3005099803-2011-01171
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    March 21, 2011
    Report Date
    March 23, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K081048
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) RELATES TO (B)(4) FOR NEEDLE DETACHMENT. ALTHOUGH THE PATIENT'S EXACT AGE WAS NOT PROVIDED, THE PATIENT IS REPORTEDLY (B)(6). ALTHOUGH THE LOT NUMBER WAS NOT PROVIDED, IT WAS REPORTED 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 MESH LEG ASSEMBLY WAS BEING LOADED INTO THE CAPIO DEVICE, THE NEEDLE DETACHED. THE NEEDLE DETACHMENT REPORTEDLY OCCURED OUTSIDE OF THE PATIENT. THE PHYSICIAN COMPLETED THE PROCEDURE WITH ANOTHER UPHOLD VAGINAL SUPPORT SYSTEM WITH NO COMPLICATIONS TO THE PATIENT, WHO IS REPORTEDLY "FINE."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1