BEUDAMED
    FDA Adverse Event Other Summary report: N

    MAXXIM MEDICAL

    MDR report key: 144580 · Received January 14, 1998

    Report

    Report Number
    1035160-1997-00011
    Event Type
    Other
    Date Received
    January 14, 1998
    Report Date
    December 11, 1997
    Manufacturer
    MAXXIM MEDICAL
    Product Code
    LRO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    HOSPITAL REPORTED THAT SCRUB NURSE DEVELOPED A RASH AFTER WEARING SURGICAL GOWN WHICH WAS A COMPONENT OF CUSTOM PROCEDURE PACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXXIM MEDICAL EYE TRAY LRO MAXXIM MEDICAL 6141153 53

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other