BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IHCSRLPA PARTIAL RAIL

    MDR report key: 11893031 · Received May 27, 2021

    Report

    Report Number
    1525712-2021-00005
    Event Type
    Injury
    Date Received
    May 27, 2021
    Report Date
    May 25, 2021
    Manufacturer
    INVACARE CORPORATION
    Product Code
    FNL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE ALLEGATION OF THE PARTIAL RAILS FALLING RESULTING IN THE USER SUSTAINING FRACTURED FINGERS COULDN¿T BE CONFIRMED, AND THE UNDERLYING CAUSE COULDN¿T BE DETERMINED. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN THE DATE/LOT CODE OF THE RAILS AND WHAT IF ANY TREATMENT WAS RECEIVED AT THE HOSPITAL, WITHOUT SUCCESS. THE RAILS ARE AWAITING RETURN, AND IF FURTHER INFORMATION BECOMES AVAILABLE A FOLLOW UP WILL BE FILED.

    Description of Event or Problem · 1

    THE REPORTER STATED THE LEFT SIDE BED RAIL WILL NOT STAY UP AND KEEPS FALLING DOWN. THE RAIL FELL AND FRACTURED 3 FINGERS ON THE CUSTOMER'S HAND AND THEY WENT TO THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    789085 IHCSRLPA PARTIAL RAIL BED, AC-POWERED ADJUSTABLE HOSPITAL FNL INVACARE CORPORATION NA:IHCSRLPA NOT AVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1