BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UPHOLD? LITE

    MDR report key: 4971298 · Received August 5, 2015

    Report

    Report Number
    3005099803-2015-02193
    Event Type
    Malfunction
    Date Received
    August 5, 2015
    Date of Event
    July 17, 2015
    Report Date
    July 20, 2015
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    OTP
    PMA / PMN Number
    K122459
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXACT AGE OF THE PATIENT IS UNKNOWN, HOWEVER, IT WAS REPORTED THE PATIENT WAS OVER 18 YEARS. THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN UPHOLD LITE WITH CAPIO SLIM WAS USED DURING A PELVIC FLOOR PROLAPSE REPAIR PROCEDURE PERFORMED ON (B)(6) 2015. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE NEEDLE DETACHED INSIDE THE PATIENT. IT WAS FOUND LODGED INSIDE THE CAPIO CAGE. THE PROCEDURE WAS COMPLETED USING ANOTHER UPHOLD LITE WITH CAPIO SLIM. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    512824 UPHOLD? LITE MESH, SURGICAL, SYNTHETIC OTP BOSTON SCIENTIFIC - MARLBOROUGH M0068318170 ML00002810

    Patients

    Seq Age Sex Outcome Treatment
    1