BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPRESSION GORE-TEX W/O FB

    MDR report key: 3537530 · Received December 26, 2013

    Report

    Report Number
    0001831750-2013-12729
    Event Type
    Malfunction
    Date Received
    December 26, 2013
    Date of Event
    December 2, 2013
    Report Date
    December 3, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    IKY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BV
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP SUBMITTED TO REPORT THE EVENT DID NOT ALLEGE A PRODUCT MALFUNCTION AND DID NOT MEET THE DEFINITION OF A COMPLAINT PER 21 CFR PART 820. CUSTOMER FEEDBACK RECEIVED STATING THAT THIS MATTER CAN BE CLOSED WITH NO ACTION NEEDED. NO MALFUNCTION ALLEGED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT THE MATTRESS MAY BE ONE OF THE FACTORS PLAYING A ROLE IN THE HIGH INCIDENCE OF ACINETOBACTER AND AFFECTING PATIENTS. NO PRODUCT MALFUNCTION HAS BEEN ALLEGED. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT THE MATTRESS MAY BE ONE OF THE FACTORS PLAYING A ROLE IN THE HIGH INCIDENCE OF ACINOBACTER AND AFFECTING PATIENTS. NO PRODUCT MALFUNCTION HAS BEEN ALLEGED. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    676631 IMPRESSION GORE-TEX W/O FB MATTRESS, FLOTATION THERAPY, NON-POWERED IKY STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1