BEUDAMED
    FDA Adverse Event Other Summary report: N

    TURN STYLE MATTRESS

    MDR report key: 80289 · Received March 27, 1997

    Report

    Report Number
    1034630-1997-00002
    Event Type
    Other
    Date Received
    March 27, 1997
    Report Date
    January 27, 1997
    Manufacturer
    BIO CLINIC
    Product Code
    FNM
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT STATED MATTRESS WAS AGGRAVATING HIS BACK INJURY, PROLONGED HIS HOSPITAL STAY AND THEN NEEDED SURGERY. LOOKING INTO THIS MATTRESS, EVEN WHEN THE PINK COVER IS UP, OR NEXT TO THE PT, WILL NOT CAUSE INJURY TO A BACK. VARIOUS MATERIALS HAVE BEEN USED FOR YRS ON HUNDREDS OF THOUSANDS OF HOSPITAL MATTRESSES. THEY ARE EASY TO CLEAN, FLAME RETARDANT AND ANTI-BACTERIOSTATIC. HOSPITALS HAVE USED THEM WITHOUT COMPLAINT ABOUT THE COVERS INJURING THE BACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TURN STYLE MATTRESS MATTRESS FNM BIO CLINIC * NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other