BEUDAMED
    FDA Adverse Event Other Summary report: N

    NON21430CNS

    MDR report key: 3115281 · Received April 29, 2013

    Report

    Report Number
    3005841380-2013-00003
    Event Type
    Other
    Date Received
    April 29, 2013
    Date of Event
    May 24, 2012
    Report Date
    April 25, 2013
    Manufacturer
    CLEARCOUNT MEDICAL SOLUTIONS
    Product Code
    GDY
    PMA / PMN Number
    K093557
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING FILED AT THE BEHEST OF FDA IN RESPONSE TO MW REPORT (B)(4). THIS COMPLAINT WAS REC'D BY CLEARCOUNT MEDICAL SOLUTIONS ON (B)(4) 2012, INVESTIGATED AND FOUND TO NOT REQUIRE AN MDR. THE ORIGINAL COMPLAINT STATED THAT A TAG WOULD NOT READ,WHICH WAS FOUND TO BE TRUE AFTER INVESTIGATION. THE ROOT CAUSE OF THE FAILURE OF THE TAG WAS FOUND TO BE A FAILED SOLDER JOINT. A REPORT OF THE INVESTIGATION WAS ISSUED TO (B)(6) BY (B)(6), VP QARA.

    Description of Event or Problem · 1

    ITEM 3 FROM REPORT (B)(4), RFID NOT DETECTED WHEN WANDED. NO PTS WERE HARMED. THIS EVENT WAS REPORTED TO CLEARCOUNT MEDICAL SOLUTIONS ON (B)(6) 2012 AS A FAILED TAG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185349 NON21430CNS 4X4 GAUZE SPONGE WITH FRID TAG GDY CLEARCOUNT MEDICAL SOLUTIONS

    Patients

    Seq Age Sex Outcome Treatment
    1