BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREVENTION PLUS GOWN

    MDR report key: 3918925 · Received June 30, 2014

    Report

    Report Number
    1417592-2014-00063
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    May 1, 2014
    Report Date
    June 20, 2014
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    FYA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRIOR TO CLOSING A SURGICAL SPINE INCISION, THE SURGEON NOTICED A PIECE OF MATERIAL IN THE WOUND. A FORCEP WAS USED TO REMOVE THE PIECE OF MATERIAL. THERE WAS NO MEDICAL TREATMENT INITIATED. THE PIECE OF MATERIAL WAS NOT RETURNED FOR EVALUATION. WE ARE UNABLE TO DETERMINE OR CONFIRM THAT THE PIECE OF MATERIAL CAME FROM THE GOWN THAT THE SURGEON WAS WEARING. A ROOT CAUSE HAS NOT BEEN DETERMINED. WE HAVE HAD NO OTHER COMPLAINTS FOR THIS ISSUE IN THE LAST YEAR. WE HAVE NOT CONFIRMED THAT THE GOWN CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. HOWEVER, DUE TO THE NEED FOR A PIECE OF MATERIAL BEING REMOVED FROM A BODY CAVITY, AND IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED.

    Description of Event or Problem · 1

    A PIECE OF MATERIAL WAS REMOVED FROM THE SURGICAL SITE PRIOR TO CLOSING THE WOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378905 PREVENTION PLUS GOWN FYA MEDLINE INDUSTRIES, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK