BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISOFLEX LAL 2860

    MDR report key: 6038452 · Received October 18, 2016

    Report

    Report Number
    0001831750-2016-00321
    Event Type
    Injury
    Date Received
    October 18, 2016
    Date of Event
    September 20, 2016
    Report Date
    September 20, 2016
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    IOQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAFETY DIRECTOR AT THE USER FACILITY STATED THAT THE INJURY SEEMS TO HAVE OCCURRED DUE TO THE PRACTICE OF USING ONE STAFF MEMBER TO PLACE AN X-RAY CASSETTE UNDER A PATIENT (RATHER THAN 2 STAFF MEMBERS TO ASSIST WITH TURNING), WHICH MAY CAUSE MORE STRESS ON THAT PERSON.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER FEELS THE COVER OF THE MATTRESS IS TOO "TACKY" AND THEY FIND IT DIFFICULT TO SLIDE X-RAY CASSETTES UNDER THE PATIENTS. IT WAS FURTHER ALLEGED A STAFF MEMBER SUSTAINED A WRIST INJURY AS A RESULT. THE STAFF MEMBER REPORTEDLY WAS SEEN BY A DOCTOR, BUT NO DETAILS REGARDING THE EXTENT OF THE ALLEGED INJURY WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    687471 ISOFLEX LAL 2860 BED, FLOTATION THERAPY, POWERED IOQ STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1