BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RECLINER

    MDR report key: 302150 · Received October 23, 2000

    Report

    Report Number
    1525712-2000-00081
    Event Type
    Injury
    Date Received
    October 23, 2000
    Report Date
    October 2, 2000
    Manufacturer
    INVACARE CORPORATION
    Product Code
    INO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    MFR RECEIVED A REPORT ALLEGING THAT TWO PTS HAVE RECEIVED CUTS TO THE LEGS THAT REQUIRED SUTURES, WHILE USING THE RECLINER. THE PT'S LEGS CAME INTO CONTACT WITH A SHARP PIECE BETWEEN THE FOOTREST OTTOMAN AND FRAME OF THE CHAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RECLINER MEDICAL CHAIR INO INVACARE CORPORATION RECLINER NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention