BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UPHOLD? LITE

    MDR report key: 3790029 · Received May 5, 2014

    Report

    Report Number
    3005099803-2014-01766
    Event Type
    Injury
    Date Received
    May 5, 2014
    Date of Event
    April 8, 2014
    Report Date
    April 8, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    OTP
    PMA / PMN Number
    K122459
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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. (B)(4) FOR THE PROBLEM OF NEEDLE DETACHMENT. 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 THE PATIENT WAS IMPLANTED WITH AN UPHOLD LITE WITH THE USE OF A CAPIO SLIM ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BULLET DETACHED FROM THE SUTURE. THE BULLET FELL OFF INSIDE THE PATIENT AND THE SUTURE REMAINED IN THE NEEDLE CARRIER OF THE DEVICE. THE PHYSICIAN IS NOT PLANNING TO RETRIEVE THE BULLET FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A SECOND UPHOLD (TM) LITE WITH CAPIO SLIM. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269364 UPHOLD? LITE MESH, SURGICAL, SYNTHETIC OTP BOSTON SCIENTIFIC - MARLBOROUGH M0068318170 ML00002063

    Patients

    Seq Age Sex Outcome Treatment
    1 Other