BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UPHOLD? LITE

    MDR report key: 3914207 · Received July 3, 2014

    Report

    Report Number
    3005099803-2014-02389
    Event Type
    Injury
    Date Received
    July 3, 2014
    Date of Event
    June 12, 2014
    Report Date
    June 12, 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

    ADDITIONAL DEVICE INFO: THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. HOWEVER, THE COMPLAINANT REPORTED THAT THE DEVICE WAS NOT EXPIRED. THE COMPLAINANT INDICATED THAT THE DEVICE 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 AN ANTERIOR REPAIR WITH MESH PROCEDURE ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, POST IMPLANTATION, THE PATIENT DEVELOPED MESH EROSION. THE PHYSICIAN WILL REMOVE THE MESH. THE PATIENT WAS REPORTED TO BE STABLE AT THE CONCLUSION OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390878 UPHOLD? LITE MESH, SURGICAL, SYNTHETIC OTP BOSTON SCIENTIFIC - MARLBOROUGH M0068318170

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention