BEUDAMED
    FDA Adverse Event Summary report: N

    NON21430CNS

    MDR report key: 3111323 · Received April 29, 2013

    Report

    Report Number
    3005841380-2013-00006
    Date Received
    April 29, 2013
    Report Date
    April 21, 2013
    Manufacturer
    MEDLINE INDUSTRIES INC
    Product Code
    GDY
    PMA / PMN Number
    K093557
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING FILED AT THE BEHEST OF FDA IN RESPONSE TO (B)(4). THIS INCIDENT WAS FIRST RELAYED TO CLEARCOUNT MEDICAL SOLUTION ON (B)(4) 2012 AND WAS DETERMINED TO NOT REQUIRE AN MDR. THE ORIGINAL COMPLAINT INDICATED THAT A TAG WOULD NOT READ. THE SUSPECT TAG WAS RETURNED TO CLEARCOUNT, EXAMINED AND FOUND TO BE DEFECTIVE. OUR RECORDS INDICATE THAT INCIDENTS OF TAG FAILURE ARE VERY RARE. THIS INFO WAS RELAYED BACK TO (B)(6) ON (B)(4) 2013. CLEARCOUNT CONTINUES TO WATCH FOR TRENDS ON THIS ISSUE. AT THIS TIME NO CORRECTIVE ACTION IS BEING TAKEN.

    Description of Event or Problem · 1

    (B)(4). RFID NOT DETECTED WHEN WANDED. NO PTS WERE HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183460 NON21430CNS 4X4 GAUZE SPONGE WITH RFID TAG GDY MEDLINE INDUSTRIES INC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1