BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UPHOLD VAGINAL SUPPORT SYSTEM

    MDR report key: 2024309 · Received March 18, 2011

    Report

    Report Number
    3005099803-2011-00845
    Event Type
    Injury
    Date Received
    March 18, 2011
    Report Date
    February 24, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K081048
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE THE LOT NUMBER WAS NOT PROVIDED, IT WAS REPORTED THAT THE DEVICE WAS NOT USED PAST ITS EXPIRY DATE.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO THE FIRST OF TWO DEVICES THAT WERE USED DURING THE SAME PROCEDURE. REFER TO ASSOCIATED MANUFACTURER REPORT #3005099803-2011-00834. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT FOLLOWING IMPLANTATION OF AN UPHOLD VAGINAL SUPPORT SYSTEM DURING A CYSTOCELE REPAIR PROCEDURE, (PROCEDURE DATE UNKNOWN) THE PATIENT "ENDED UP IN RETENTION FOR 2 WEEKS" (DATE OF RETENTION ONSET UNKNOWN) AND WAS CATHETERIZED FOR THAT TIME UNTIL IT RESOLVED ON ITS OWN. THE PATIENT'S CURRENT CONDITION WAS REPORTED TO BE "COMPLETELY FINE." ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. 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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SOLYX SINGLE-INCISION SLING SYSTEM