BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPPRELIN LA IMPLANT

    MDR report key: 2193250 · Received July 26, 2011

    Report

    Report Number
    2193250
    Event Type
    Malfunction
    Date Received
    July 26, 2011
    Date of Event
    July 20, 2011
    Report Date
    July 25, 2011
    Manufacturer
    ENDO PHARMACEUTICAL
    Product Code
    MDM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SUPPRELIN LA IMPLANT PLACED (B)(6) 2010. DURING EXPLANTATION ON (B)(6) 2011 IMPLANT FOUND BROKEN IN THREE PIECES. SURGEON INITIALLY ABLE TO RETRIEVE ONE PORTION OF IMPLANT AND UNABLE TO PALPATE REMAINING DEVICE. PLAIN FILM RADIOLOGY DONE BUT UNABLE TO SEE DEVICE - NOT RADIOPAQUE. SONOGRAPHY USED WITH ASSISTANCE OF ANOTHER PHYSICIAN AND REMAINING 2 FRAGMENTS REMOVED. PER SURGEON, THIS WAS A VARIATION TO HIS PRIOR EXPERIENCE WITH THIS DEVICE. THIS WAS ONE OF FOUR IMPLANTS THAT BROKE DURING EXPLANTATION IN A 2 DAY PERIOD. SURGEON VERBALIZED THE INTEGRITY OF IMPLANTS PLACED APPROXIMATELY ONE YEAR AGO ARE INFERIOR TO IMPLANTS IN PRIOR 18 MONTHS AND BEYOND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPPRELIN LA IMPLANT BODY/CAPSULE OF HORMONE IMPLANT MDM ENDO PHARMACEUTICAL 67979-002-01 9K2331

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Other