BEUDAMED
    FDA Adverse Event Other Summary report: N

    NON 21430NCS

    MDR report key: 3115264 · Received April 29, 2013

    Report

    Report Number
    3005841380-2013-00002
    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 HAD A LOW READ RANGE. WHEN THE TAG WAS TESTED AT CLEARCOUNT THE TAG MET THE READ RANGE SPECIFICATIONS. A REPORT OF THE INVESTIGATION WAS ISSUED TO (B)(6).

    Description of Event or Problem · 1

    ITEM 2 FROM REPORT (B)(4), RFID HAD CHIP WITH A LOW READ RANGE. NO PTS WERE HARMED. THIS EVENT WAS REPORTED TO CLEARCOUNT MEDICAL SOLUTIONS ON (B)(6) 2012 AS TAG WITH LOW READ RANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185345 NON 21430NCS 4X4 GUAZE SPONGE WITH RFID TAG GDY CLEARCOUNT MEDICAL SOLUTIONS

    Patients

    Seq Age Sex Outcome Treatment
    1