BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOWRAP

    MDR report key: 1345115 · Received February 4, 2009

    Report

    Report Number
    9611451-2009-00029
    Event Type
    Malfunction
    Date Received
    February 4, 2009
    Report Date
    January 5, 2009
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    KME
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). THE DEVICE IS CLASS I. THE ORIGINAL DEVICE WAS DISCARDED BY THE HOSPITAL. A DEVICE FROM THE SAME LOT IS EN ROUTE TO THE MANUFACTURER. A FOLLOW UP REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    A HOSPITAL REPORTED THAT THE NC100 NEOWRAP PLASTIC FILM BABY WRAPS WERE FUSED TOGETHER. "PATIENT CARE WAS COMPROMISED BECAUSE OF THIS DEFECT." FURTHER INQUIRIES BY THE MANUFACTURER REVEALED THAT THE HOSPITAL HAD EXPERIENCED THIS ON 2 OTHER PATIENTS PREVIOUSLY, BUT WERE UNABLE TO PROVIDE FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEOWRAP KME FISHER & PAYKEL HEALTHCARE, LTD. NC100-10

    Patients

    Seq Age Sex Outcome Treatment
    1