BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UPHOLD VAGINAL SUPPORT SYSTEM

    MDR report key: 2013837 · Received March 10, 2011

    Report

    Report Number
    3005099803-2011-00784
    Event Type
    Malfunction
    Date Received
    March 10, 2011
    Date of Event
    February 15, 2011
    Report Date
    February 15, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K081048
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING A PELVIC FLOOR REPAIR PROCEDURE USING AN UPHOLD VAGINAL SUPPORT SYSTEM, AS THE SECOND MESH LEG ASSEMBLY WAS BEING PULLED THROUGH THE SACROSPINOUS LIGAMENT, THE SUTURE (WITH THE NEEDLE AT THE END) "POPPED OUT OF THE DILATOR PORTION OF THE [MESH] LEG ASSEMBLY." REPORTEDLY, THE SUTURE DETACHED OUTSIDE OF THE PATIENT. THE PHYSICIAN REPORTEDLY 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 1ML0111102

    Patients

    Seq Age Sex Outcome Treatment
    1