BEUDAMED
    FDA Adverse Event Other Summary report: N

    PONTO IMPLANT WITH ABUTMENT

    MDR report key: 3142284 · Received May 24, 2013

    Report

    Report Number
    3007367732-2013-00011
    Event Type
    Other
    Date Received
    May 24, 2013
    Date of Event
    March 20, 2013
    Report Date
    May 24, 2013
    Manufacturer
    OTICON MEDICAL AB
    Product Code
    MAH
    PMA / PMN Number
    K121228
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    WAS INFORMED THAT PT HAD A HEMATOMA APPROX TWO WEEKS POSTOPERATIVE. SURGEON FIRST ATTEMPTED TO NEEDLE ASPIRATE THE HEMATOMA AND APPLIED PRESSURE DRESSING. THE HEMATOMA RECURRED. AT THAT TIME, THE PT WAS TAKEN TO THE OPERATING ROOM AND THE WOUND WAS EXPOSED AND A LARGE HEMATOMA WAS DRAINED. A PRESSURE DRESSING WAS REAPPLIED. A SMALLER HEMATOMA RECURRED AND WAS DRAINED IN THE OFFICE WHERE A BOLSTER PRESSURE DRESSING WAS SUTURED IN PLACE. THE IMPLANT SITE IS NOW HEALED AND PT IS TO BE FIT WITH SOUND PROCESSOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230576 PONTO IMPLANT WITH ABUTMENT BONE ANCHORED HEARING IMPLANT MAH OTICON MEDICAL AB M51136 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R