BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UPHOLD? LITE

    MDR report key: 3770649 · Received April 24, 2014

    Report

    Report Number
    3005099803-2014-01680
    Event Type
    Injury
    Date Received
    April 24, 2014
    Report Date
    March 28, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    OTP
    PMA / PMN Number
    K122459
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN UPHOLD (TM) LITE DEVICE WAS USED DURING AN UPHOLD LITE IMPLANTATION PROCEDURE. ACCORDING TO THE COMPLAINANT, AFTER THE PROCEDURE, PATIENT COMPLAINED OF PAIN. THE PHYSICIAN THINKS HE MAY HAVE TO REMOVE THE DEVICE. NO MORE INFORMATION REGARDING THIS EVENT HAS BEEN PROVIDED. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249742 UPHOLD? LITE MESH, SURGICAL, SYNTHETIC OTP BOSTON SCIENTIFIC - MARLBOROUGH M0068318170

    Patients

    Seq Age Sex Outcome Treatment
    1 Other