BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALPHA RESPONSE

    MDR report key: 3140305 · Received May 24, 2013

    Report

    Report Number
    1419652-2013-00137
    Event Type
    Injury
    Date Received
    May 24, 2013
    Report Date
    May 13, 2013
    Manufacturer
    GETINGE (SUZHOU) CO LTD
    Product Code
    FNM
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT GOT PRESSURE ULCER AT HEELS WITH ALPHA RESPONSE. REF MFR # 1419652-2013-00137.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232363 ALPHA RESPONSE PAC FNM GETINGE (SUZHOU) CO LTD 464EUR

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention