BEUDAMED
    FDA Adverse Event Other Summary report: N

    GEMINI

    MDR report key: 4253574 · Received November 10, 2014

    Report

    Report Number
    MW5039088
    Event Type
    Other
    Date Received
    November 10, 2014
    Report Date
    November 10, 2014
    Manufacturer
    MEDLINE
    Product Code
    FRG
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IN REFERENCE TO MEDLINE'S SEQUENTIAL WRAP, PROPER "HARD COPY" LABELING IS REQUIRED WITH ALL MEDICAL DEVICES. HOW IS MEDLINE ABLE TO NOT PROVIDE AN IFU IN THEIR CASES OF WRAP? ALSO, IN REFERENCE TO MEDLINE'S MOST RECENT DFU THEY CLAIM TO PREVENT WET PACKS AND THAT THEY HAVE A 2-YEAR MPI FOR PRE-VAC, GRAVITY, AND UNTIL OPENED MPI FOR EO. I'VE REVIEWED THE 510(K) [KI 13353] AND AM ASKING WHERE THOSE CLAIMS APPEAR IN THE CLEARED 510(K) LETTER?

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722986 GEMINI MEDLINE FRG MEDLINE

    Patients

    Seq Age Sex Outcome Treatment
    1