BEUDAMED
    FDA Adverse Event Other Summary report: N

    LUMEX

    MDR report key: 167396 · Received May 7, 1998

    Report

    Report Number
    167396
    Event Type
    Other
    Date Received
    May 7, 1998
    Date of Event
    May 4, 1998
    Report Date
    May 7, 1998
    Manufacturer
    LUMEX CORPORATION
    Product Code
    INM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE THIRD FINGER OF THE RIGHT HAND HAD THE DISTAL PHALANX AMPUTATED AND THE FOURTH FINGER OF THE RIGHT HAND HAD A ONE CM LACERATION. THIS EVENT HAPPENED WHILE THE RESIDENT WAS IN A 3-POSITION ORTHO-BIOTIC RECLINER, A GERICHAIR. THE GERI-CHAIR WAS REPOSITIONED TO TAKE THE RESIDENT TO HIS ROOM BEDTIME CARE. THE RESIDENT HAD HIS HAND DOWN ALONG HIS SIDE AND GOT HIS PHALANX CAUGHT IN THE POSITIONING MECHANISM (CARRIAGE) AND THE PHALANX WAS AMPUTATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUMEX 3 POSITION ORTHO-BIOTIC RECLINER INM LUMEX CORPORATION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Other NURSING RE-HAB 3 TIMES A WEEK.