BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCARE

    MDR report key: 2419393 · Received January 11, 2012

    Report

    Report Number
    9616086-2012-00003
    Event Type
    Injury
    Date Received
    January 11, 2012
    Date of Event
    December 12, 2011
    Report Date
    January 10, 2012
    Manufacturer
    DJO LLC.
    Product Code
    IPG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADD'L INFO WAS PROVIDED. SPECIFIC INFO OF THE INVOLVED DEVICE AND THE NATURE OF THE CLAIMED INJURIES IS NOT KNOWN AT THIS TIME. THE PRODUCT WAS NOT RETURNED FOR EVAL OR INVESTIGATION.

    Description of Event or Problem · 1

    RECEIVED NOTIFICATION FROM A LAW FIRM CLAIMING THAT THEIR CLIENT FELL "[AS] A RESULT OF THE POST OPERATIVE BOOT MANUFACTURED BY PRO-CARE [¿] AND AS A RESULT OF THIS FALL, SHE SUSTAINED SUBSTANTIAL AND PERMANENT INJURIES FOR WHICH SHE WILL REQUIRE SURGICAL INTERVENTION." NO ADD'L INFO WAS PROVIDED. SPECIFIC INFO OF THE INVOLVED DEVICE AND THE NATURE OF THE CLAIMED INJURIES IS NOT KNOWN AT THIS TIME. THE PRODUCT WAS NOT RETURNED FOR EVAL OR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROCARE PROCARE POST OP BOOT IPG DJO LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other