BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UPHOLD VAGINAL SUPPORT SYSTEM

    MDR report key: 2810398 · Received October 31, 2012

    Report

    Report Number
    3005099803-2012-05213
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Report Date
    July 12, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K081048
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION A REVIEW OF THE MANUFACTURING RECORDS FOR THIS LOT SHOWED NO EVIDENCE OF A MANUFACTURING-RELATED POTENTIAL CAUSE FOR THIS EVENT. THE CAPIO DEVICE WAS NOT RECEIVED FOR ANALYSIS. THE LEAD SUTURE WITH THE NEEDLE AT THE END WAS RECEIVED DETACHED FROM THE SOLID BLUE DILATOR OF THE MESH ASSEMBLY.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING THE INSERTION PROCEDURE, THE DEVICE WAS NOT STABLE ENOUGH TO ANCHOR IN PLACE. ALL OTHER INFORMATION IS UNKNOWN. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UPHOLD VAGINAL SUPPORT SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH M0068317080 ML00000468

    Patients

    Seq Age Sex Outcome Treatment
    1