BEUDAMED
    FDA Adverse Event Other Summary report: N

    DEMR X-RAY SPG 4X4 16 PLY ALT

    MDR report key: 3767708 · Received April 15, 2014

    Report

    Report Number
    1282497-2014-00024
    Event Type
    Other
    Date Received
    April 15, 2014
    Report Date
    April 2, 2014
    Manufacturer
    ALLMED MEDICAL PRODUCTS
    Product Code
    GDY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2014 THAT A CUSTOMER HAD AN ISSUE WITH AN X-RAY SPONGE. THE CUSTOMER REPORTS THAT THEY ARE HAVING PROBLEMS WITH THE 4X4 GAUZE IN THE MINOR LAP PACKS. THE CUSTOMER REPORTED THEY ARE VERY CHEAP AND FALLING APART. THIS ISSUE WAS NOTICED WITH A PT IN SURGERY. THE DOCTOR AND SCRUB TECH REMOVED THE FRAYED PIECES FROM THE SURGERY SITE AND OPENED ANOTHER X-RAY SPONGE PACK. THE PT'S SURGERY WAS A HERNIA CASE AND THE FRAYING WAS NOTICED IMMEDIATELY. THE PT WAS DOING WELL AFTER SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230749 DEMR X-RAY SPG 4X4 16 PLY ALT X-RAY SPONGE GDY ALLMED MEDICAL PRODUCTS 441601A 13319A

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other