BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISOFLEX

    MDR report key: 1913473 · Received November 24, 2010

    Report

    Report Number
    1313850-2010-00003
    Event Type
    Malfunction
    Date Received
    November 24, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 19, 2010
    Manufacturer
    GAYMAR INDUSTRIES, INC.
    Product Code
    FNM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DISPOSED OF THE MATTRESS. DEVICE SERIAL NUMBER UNAVAILABLE.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT AN ACCOUNT HAD AN ISOFLEX MATTRESS THAT WAS RUINED BECAUSE THE ZIPPER ON THE COVER BROKE AND LET FLUIDS INSIDE THE MATTRESS. ACCORDING TO THE CUSTOMER, THEY HAD TO DISPOSE OF THE MATTRESS BECAUSE A (B)(6) PATIENT WAS ON THE MATTRESS. NO ADVERSE CONSEQUENCES HAVE BEEN REPORTED. EVENT DATE WAS APPROXIMATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISOFLEX NON-POWERED FLOTATION THERAPY MATTRESS FNM GAYMAR INDUSTRIES, INC. 2800100015

    Patients

    Seq Age Sex Outcome Treatment
    1