BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_MEDICAL_PRODUCT

    MDR report key: 2990439 · Received March 5, 2013

    Report

    Report Number
    0001831750-2013-01743
    Event Type
    Injury
    Date Received
    March 5, 2013
    Date of Event
    February 18, 2013
    Report Date
    February 18, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FMW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE OVERLAY MODEL AND LOT NUMBER ARE UNKNOWN. THE PRODUCT IS NOT BEING RETURNED TO THE MANUFACTURER FOR EVALUATION; NO PRODUCT MALFUNCTION IS ALLEGED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE NURSE MANAGER THAT A PATIENT ALLEGEDLY FELL DUE TO THE MATTRESS OVERLAY'S INCREASED HEIGHT AND, ALONG WITH THE SHEETS BEING USED, THE OVERLAY SEEMED SLIPPERY. THE PATIENT ALLEGEDLY REQUIRED MEDICAL INTERVENTION. THE OVERLAY MODEL AND LOT NUMBER IS UNKNOWN AS THE INCIDENCE WAS NOT RECORDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93719 UNKNOWN_MEDICAL_PRODUCT UNKNOWN FMW STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1