BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WHITMEYER HEADREST

    MDR report key: 3799696 · Received April 22, 2014

    Report

    Report Number
    2937137-2014-00014
    Event Type
    Injury
    Date Received
    April 22, 2014
    Date of Event
    April 7, 2014
    Report Date
    April 7, 2014
    Manufacturer
    SUNRISE MEDICAL (US) LLC.
    Product Code
    IMS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IT APPEARS THAT THE WHEELCHAIR AND/OR PARTS INVOLVED IN THIS INCIDENT ARE BEING RETURNED TO SUNRISE MEDICAL (US) LLC. IF AND WHEN THE CHAIR/PARTS ARE REC'D, OUR INTERNAL FAILURE INVESTIGATOR WILL COMPLETE THE INVESTIGATION AND A F/U REPORT WILL BE FILED.

    Description of Event or Problem · 1

    A DEALER REPORTED TO SUNRISE MEDICAL THAT AN END-USER HAS SUSTAINED SKIN BREAKDOWN BEHIND HER RIGHT EAR. THE DEALER IS ALLEGING THAT SHARP METAL EDGES ON THE HEADREST PAD ARE WHAT IS CAUSING THE SKIN BREAKDOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242189 WHITMEYER HEADREST HEADREST IMS SUNRISE MEDICAL (US) LLC. HU-MTLCV

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention