BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UPHOLD VAGINAL SUPPORT SYSTEM

    MDR report key: 1940919 · Received December 29, 2010

    Report

    Report Number
    3005099803-2010-05254
    Event Type
    Malfunction
    Date Received
    December 29, 2010
    Date of Event
    December 1, 2010
    Report Date
    December 9, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K081048
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE OF THIS EVENT. HOWEVER, IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING AN ANTERIOR PELVIC FLOOR REPAIR PROCEDURE USING AN UPHOLD VAGINAL SUPPORT SYSTEM, THE BLUE DILATOR FROM THE SECOND MESH LEG ASSEMBLY DETACHED "IN THE MIDDLE" AS IT WAS BEING PULLED BY HEMOSTATS THROUGH THE LIGAMENT. THE PHYSICIAN REPORTED THAT " LITTLE BUNCHING [OCCURED] BUT NOT AS MUCH AS USUAL" AND THAT "RESISTANCE WAS FELT." REPORTEDLY, NO DEVICE PIECES FELL INTO THE PATIENT. THE PHYSICIAN REMOVED THIS DEVICE AND COMPLETED THE PROCEDURE WITH ANOTHER UPHOLD VAGINAL SUPPORT SYSTEM WITH NO COMPLICATIONS TO THE PATIENT, WHO IS REPORTEDLY "FINE" POST-PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UPHOLD VAGINAL SUPPORT SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH M0068317080 1ML0083103

    Patients

    Seq Age Sex Outcome Treatment
    1 48 DA