BEUDAMED
    FDA Adverse Event Other Summary report: N

    PARKER BATH

    MDR report key: 1880498 · Received October 14, 2010

    Report

    Report Number
    9611530-2010-00076
    Event Type
    Other
    Date Received
    October 14, 2010
    Date of Event
    August 13, 2010
    Report Date
    October 5, 2010
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    ILJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE REPORTING ACCORDING TO EXEMPTION NO (B)(4). INCIDENTS INVOLVING MEDICAL DEVICES MFG BY ARJO HOSPITAL EQUIPMENT (B)(4) WILL BE REPORTED BY US, THE LEGAL MFR, ARJO HOSPITAL EQUIPMENT (B)(4) ON BEHALF OF OUR SALES AND DISTRIBUTION COMPANY IN THE USA, ARJO INC, (B)(4). ADD'L INFO WILL BE PROVIDED UPON CONCLUSION OF THE MFR'S INVESTIGATION.

    Description of Event or Problem · 1

    AS STATED BY THE AHUS SERVICE TECH 10/5/2010: "THE BATH WAS COMPLETE, DOOR IN THE OPEN POSITION, ONE NURSING ASSISTANT ASSISTING RESIDENT TO EXIT BATH. WHEN THE RESIDENT SLID OVER THE CLOSET JET ASSAY TO THE DOOR AND STOOD UP, THE NURSING ASSISTANT NOTICED BLEEDING AND A SKIN TEAR ON THE PT'S SCROTUM. THE PT WAS THEN TRANSPORTED TO THE ER WHERE HE RECEIVED A NUMBER OF SUTURES." (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARKER BATH BATH, HYDRO-MASSAGE ILJ ARJO HOSPITAL EQUIPMENT AB AL14110-US

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR