BEUDAMED
    FDA Adverse Event Other Summary report: N

    DERM X-RAY SPG 4X8 12 PLY ALT

    MDR report key: 3780807 · Received April 18, 2014

    Report

    Report Number
    1282497-2014-00030
    Event Type
    Other
    Date Received
    April 18, 2014
    Report Date
    April 1, 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)(4) 2014 THAT A CUSTOMER HAD AN ISSUE WITH A X-RAY 4X8 SPONGE. THE CUSTOMER STATES THE GAUZE IS FALLING APART. THIS WAS USED BY THE NEURO TEAM AND THE ISSUE WAS NOTICED DURING USE. THE CUSTOMER IS TAKING THE RAYTEC UNFOLDING AND ELONGATING THEM TO ONE INCH WIDE SO THAT THEY CAN EASILY BE USED TO CLEAR THE VISION FOR THE SURGEON DOWN IN THE CAVITY THAT IS BEING OPERATED ON. THIS OCCURRED DURING AN ACDF CASE AND THE CUSTOMER CLARIFIED THE GAUZE WAS NOT ACTUALLY FALLING APART, IT WAS SHEDDING FIBERS THAT WERE FREE IN THE GAUZE ITSELF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238941 DERM X-RAY SPG 4X8 12 PLY ALT X-RAY 4X8 SPONGE GDY ALLMED MEDICAL PRODUCTS 441603A 13272A

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other