BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UPHOLD VAGINAL SUPPORT SYSTEM

    MDR report key: 2842558 · Received November 21, 2012

    Report

    Report Number
    3005099803-2012-05431
    Event Type
    Injury
    Date Received
    November 21, 2012
    Date of Event
    November 1, 2012
    Report Date
    October 31, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K081048
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    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 PROCEDURE ON (B)(6), 2012. THE PROCEDURE WENT WELL. DURING A POST-PROCEDURE EXAMINATION ON (B)(6), 2012, THE PATIENT PRESENTED WITH MODERATE BUTTOCK PAIN ON HER LEFT SIDE, WHICH THE PHYSICIAN ATTRIBUTES TO FIXATION OF THE UPHOLD MESH LEG THROUGH THE SACROSPINOUS LIGAMENT. THE PHYSICIAN ASSUMES THAT THE PAIN WILL RESOLVE ON ITS OWN BUT PRESCRIBED ANTI-INFLAMMATORY MEDICATION (SPECIFICS UNKNOWN) TO THE PATIENT. REPORTEDLY, THE PHYSICIAN WILL REVIEW THE PATIENT'S CONDITION AGAIN THREE WEEKS FROM THIS EXAMINATION DATE.

    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