BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UPHOLD VAGINAL SUPPORT SYSTEM

    MDR report key: 2761082 · Received September 26, 2012

    Report

    Report Number
    3005099803-2012-04227
    Event Type
    Injury
    Date Received
    September 26, 2012
    Report Date
    September 7, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K081048
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WAS NOT USED PAST ITS EXPIRY DATE. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THE PATIENT WAS IMPLANTED WITH AN UPHOLD VAGINAL SUPPORT SYSTEM DURING A PELVIC FLOOR RECONSTRUCTION PROCEDURE. ACCORDING TO THE COMPLAINANT, THE PATIENT PRESENTED WITH URINARY RETENTION EITHER ON THE SAME DAY, OR ON THE DAY IMMEDIATELY AFTER THE PROCEDURE. THE PATIENT SELF-CATHETERIZED FOR ONE WEEK, AND THE RETENTION EVENTUALLY RESOLVED WITHOUT ANY FURTHER INTERVENTION. THE PATIENT IS REPORTEDLY IN FINE CONDITION.

    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 Required Intervention