BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 3952943 · Received July 10, 2014

    Report

    Report Number
    3008007426-2014-00001
    Event Type
    Malfunction
    Date Received
    July 10, 2014
    Report Date
    July 9, 2014
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Distributor report

    Narratives

    Additional Manufacturer Narrative · 1

    LINET IS AWARE OF THE POTENTIAL ADVERSE EVENTS THAT COULD OCCUR GIVEN THE CONTINUED MISUSE OF THE SYMBIOSO MATTRESS COVERS AND PLANS THE FOLLOWING ACTIONS: SHARE THE CONCLUSION OF OUR INVESTIGATION WITH THE USER FACILITY MAKING THE COMPLAINT AND PROVIDE THE USER FACILITY THE OPPORTUNITY TO PURCHASE NEW MATTRESS COVERS. PROVIDE A REMINDER TO OUR CUSTOMERS USING THE MATTRESS COVERS THE IMPORTANCE OF FOLLOWING THE PRODUCT CLEANING AND INSPECTION INSTRUCTIONS. THIS REMINDER WILL INCLUDE THE FDA'S SAFETY COMMUNICATION, "DAMAGED OR WORN COVERS FOR MEDICAL BED MATTRESSES POSE RISK OF CONTAMINATION AND PT INFECTION: FDA SAFETY COMMUNICATION." PROVIDE PRODUCT FEEDBACK INTO THE SYMBIOSO MATTRESS COVER DESIGN TO CONSIDER INCLUDING ADDITIONAL CLEANING AGENTS AND PROTOCOLS. THIS INFO MAY LEAD TO A FUTURE PRODUCT ENHANCEMENT AS DETERMINED BY OUR DESIGN CONTROLS PROCEDURE. NO, IT WAS NOT RETURNED, BUT WE DID AN EVAL REPORT.

    Description of Event or Problem · 1

    A PROBLEM HAS BEEN IDENTIFIED WHERE THE SYMBIOSO MATTRESS COVER HAS WORN AND FAILS TO PREVENT FLUID FROM LEAKING INTO THE MATTRESS BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403849 NONE FNL

    Patients

    Seq Age Sex Outcome Treatment
    1