BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTINE TRANSBLEPH

    MDR report key: 861527 · Received June 5, 2007

    Report

    Report Number
    3003644133-2007-00004
    Event Type
    Injury
    Date Received
    June 5, 2007
    Date of Event
    April 30, 2007
    Report Date
    April 30, 2007
    Manufacturer
    COAPT SYSTEMS, INC.
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE PHYSICIAN, PATIENT REPORTED SYMPTOMS OF PAIN AT APPROXIMATELY FIVE (5) WEEKS POST-OPERATION. NO SYMPTOMS OF INFECTION REPORTED. PHYSICIAN PRESCRIBED MEDICATION FOR NEURALGIC PAIN, BUT PATIENT WAS NOT SATISFIED. APPROXIMATELY THREE (3) MONTHS POST-OPERATION, PHYSICIAN REMOVED DEVICES TO ASSUAGE PATIENT'S CONCERNS. HEALING HAD OCCURRED AND COSMETIC BENEFIT WAS MAINTAINED (BROW REMAINED LIFTED). PATIENT AND PHYSICIAN WERE SATISFIED WITH RESULTS. SURGERY CENTER STATES THAT EXPLANTED DEVICES ARE BEING RETURNED TO MANUFACTURER FOR INVESTIGATION. DEVICES WILL BE EVALUATED ONCE RECEIVED. A FOLLOW-UP MDR WILL BE SUBMITTED WITH ANY ADDITIONAL INFORMATION AS NECESSARY ONCE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS ALLEGED THAT PHYSICIAN REMOVED TWO (2) ENDOTINE TRANSBLEPH DEVICES THREE (3) MONTHS POST-OPERATIVELY. PATIENT REPORTED SYMPTOMS OF PAIN AT SURGICAL SITE AND REQUESTED THE DEVICES BE TAKEN OUT. NO EVIDENCE OF INFECTION AT SURGICAL SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTINE TRANSBLEPH SMOOTH METALLIC BONE FIXATION FASTENER HWC COAPT SYSTEMS, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention