BEUDAMED
    FDA Adverse Event Summary report: N

    NON21430CNS

    MDR report key: 3111320 · Received April 29, 2013

    Report

    Report Number
    3005841380-2013-00008
    Date Received
    April 29, 2013
    Report Date
    April 21, 2013
    Manufacturer
    MEDLINE INDUSTRIES INC
    Product Code
    GDY
    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 MW REPORT (B)(4). CLEARCOUNT HAS INVESTIGATED THIS INCIDENT IN CONJUNCTION WITH MEDLINE INDUSTRIES, THE REGISTERED MFR OF THE PRODUCT. THE FACILITY REPORTED THAT THERE WAS A PACK OF 4X4 SPONGES WITH AN INCORRECT NUMBER OF SPONGES, BUT THAT NO PTS WERE HARMED. THE SAMPLE WAS NOT RETURNED FOR EVAL AND NO LOT NUMBER WAS PROVIDED. THIS INCIDENT APPARENTLY OCCURRED APPROXIMATELY ONE YEAR PRIOR BUT IT HAD NOT PREVIOUSLY BEEN REPORTED TO US. WE HAVE NO DETAILS PERTAINING TO THE PT. WE HAVE NO REPORTS OF INJURY OR NEED FOR MEDICAL/SURGICAL INTERVENTION. WE HAVE NO TREND FOR THIS ISSUE WITH THIS DEVICE. WITHOUT A SAMPLE TO EVALUATE, WE HAVE NOT CONFIRMED THE ISSUE AND ROOT CAUSE WAS NOT DETERMINED. AT THIS TIME NO CORRECTIVE ACTION IS BEING TAKEN. THE ISSUE WILL BE MONITORED FOR TRENDING. THIS MEDWATCH IS BEING FILED IN RESPONSE TO THE MEDWATCH FILED BY THE FACILITY. MULTIPLE ATTEMPTS WERE MADE TO CONTACT THE FACILITY IN AN ATTEMPT TO GATHER MORE DETAILS.

    Description of Event or Problem · 1

    ITEM 8 FROM REPORT (B)(4). INCORRECT NUMBER OF SPONGES IN PACK. NO PTS WERE HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185286 NON21430CNS 4X4 GAUZE SPONGE WITH RFID TAG GDY MEDLINE INDUSTRIES INC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other