BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRATINE FOREHEAD

    MDR report key: 1020674 · Received March 27, 2008

    Report

    Report Number
    3003644133-2008-00011
    Event Type
    Injury
    Date Received
    March 27, 2008
    Report Date
    February 28, 2008
    Manufacturer
    COAPT SYSTEMS, INC.
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS A VERY LOW INCIDENCE OF REACTION TO THE COMPONENTS OF THIS DEGRADABLE DEVICE. WE HAVE DISCUSSED THE SURGICAL PROCEDURE WITH THE PHYSICIAN, WHO IMPLANTS IN THE MID FOREHEAD AREA. THIS IS UNUSUAL PLACEMENT AND NOT IN ACCORDANCE WITH RECOMMENDATIONS IN THE INSTRUCTIONS FOR USE. HOWEVER, IT IS INCONCLUSIVE AS TO WHETHER THERE IS A RELATIONSHIP BETWEEN THIS PLACEMENT AND THE APPARENT ENCAPSULATION. IN THE EVENT THAT THE DEVICES ARE EXPLANTED, WE HAVE REQUESTED THE RETURN OF EXTRACTED DEVICES FOR ANALYSIS. IF MORE INFORMATION BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT FIVE MONTHS AFTER THE SURGICAL PROCEDURE THE DEVICES HAVE NOT ABSORBED AND APPEAR ENCAPSULATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRATINE FOREHEAD SMOOTH METALLIC BONE FIXATION FASTNER HWC COAPT SYSTEMS, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention