BEUDAMED
    FDA Adverse Event Other Summary report: N

    ERM X-RAY SPG 4X4 16 PLY ALT

    MDR report key: 3803008 · Received April 30, 2014

    Report

    Report Number
    1282497-2014-00032
    Event Type
    Other
    Date Received
    April 30, 2014
    Report Date
    April 11, 2014
    Manufacturer
    ALLMED MEDICAL PRODUCTS
    Product Code
    GDY
    Product Problem
    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 STATES THE GAUZE IS FRAYING. THIS WAS NOTICED DURING USE. THE PROCEDURE WAS A SPINE SURGERY. THERE WAS NO MEDICAL INTERVENTION OTHER THAN IRRIGATION AND SUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259182 ERM X-RAY SPG 4X4 16 PLY ALT X-RAY SPONGE GDY ALLMED MEDICAL PRODUCTS 441601A 13103A

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK