BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UPHOLD VAGINAL SUPPORT SYSTEM

    MDR report key: 2240176 · Received September 9, 2011

    Report

    Report Number
    3005099803-2011-02953
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    August 18, 2011
    Report Date
    August 18, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K081048
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING AN ANTERIOR CYSTOCELE REPAIR PROCEDURE USING AN UPHOLD VAGINAL SUPPORT SYSTEM, AS THE PHYSICIAN WAS PULLING THE LEG ASSEMBLY THROUGH THE PATIENT'S LEFT SACROSPINOUS LIGAMENT, THE SLEEVE DETACHED OUTSIDE THE PATIENT. REPORTEDLY, THE SLEEVE HAD NOT BEEN CUT PRIOR TO THE DETACHMENT. THE PHYSICIAN REMOVED THE DEVICE FROM THE PATIENT AND COMPLETED THE PROCEDURE USING ANOTHER UPHOLD VAGINAL SUPPORT SYSTEM, WITH NO COMPLICATIONS TO THE PATIENT, WHO IS REPORTEDLY FINE AND IS OVER 18 YEARS OF AGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UPHOLD VAGINAL SUPPORT SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH M0068317080 1ML1020301

    Patients

    Seq Age Sex Outcome Treatment
    1