BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GOBED II

    MDR report key: 4093954 · Received September 16, 2014

    Report

    Report Number
    0001831750-2014-03257
    Event Type
    Injury
    Date Received
    September 16, 2014
    Date of Event
    August 22, 2014
    Report Date
    August 22, 2014
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FNL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER DID NOT RECORD SERIAL NUMBERS IN ORDER FOR MANUFACTURER TO PERFORM AN EVALUATION. CUSTOMER REPAIRED BED AND RETURNED TO SERVICE. CUSTOMER PERFORMED EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PIECES FROM A DELAMINATED CASTER JAMMED IN THE WHEEL CAUSING THE BED TO UNEXPECTEDLY STOP. THIS ALLEGEDLY CAUSED A CAREGIVER BACK PAIN WHICH RESULTED IN SEVERAL MONTHS OF CHIROPRACTOR TREATMENTS AND THE USE OF A NONPRESCRIPTION ANTI-INFLAMMATORY. THERE WAS PATIENT INVOLVEMENT, HOWEVER NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571414 GOBED II BED, AC-POWERED ADJUSTABLE HOSPITAL FNL STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1