BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURITY SPG GZ 4X4 12P STR 10'S

    MDR report key: 2023998 · Received March 14, 2011

    Report

    Report Number
    1018120-2011-00003
    Event Type
    Malfunction
    Date Received
    March 14, 2011
    Report Date
    March 8, 2011
    Manufacturer
    COVIDIEN
    Product Code
    EFQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    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 STATES THE GAUZE FRAYED IN A PATIENT'S WOUND. WOUND CARE NURSE HAD TO FLUSH THE WOUND WITH SALINE AND ADMINISTER MIST THERAPY IN ATTEMPTS TO REMOVE ALL THE LINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CURITY SPG GZ 4X4 12P STR 10'S GAUZE SPONGE EFQ COVIDIEN 397110 110000148062

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK