BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    90102387 DERMACEA GZE SPG 4X4 8PLY STR

    MDR report key: 2392079 · Received December 15, 2011

    Report

    Report Number
    1018120-2011-00026
    Event Type
    Malfunction
    Date Received
    December 15, 2011
    Date of Event
    December 8, 2011
    Report Date
    December 9, 2011
    Manufacturer
    COVIDIEN
    Product Code
    GDY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: (B)(4) 2011. 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) 2011 THAT A CUSTOMER HAD AN ISSUE WITH A GAUZE SPONGE. THE CUSTOMER REPORTS THAT WHILE USING THE GAUZE SPONGE TO DEBRIDE AND PROTECT THE WOUND BED, THE END OF THE GAUZE SPONGE IS FRAYING OUT OF THE PACKAGE, FALLING APART DURING USE, AND REMAINING IN THE WOUND BED ONCE THE SPONGE IS REMOVED. IN RESPONSE, THE CUSTOMER STATES THAT THE NURSE WAS ABLE TO SUCCESSFULLY REMOVE THE PIECES OF THE SPONGE FROM THE WOUND BED WITH NO FURTHER MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 90102387 DERMACEA GZE SPG 4X4 8PLY STR GAUZE SPONGE GDY COVIDIEN 441001 110002462462

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK