BEUDAMED
    FDA Adverse Event Other Summary report: N

    MAXXIM MEDICAL

    MDR report key: 115153 · Received August 22, 1997

    Report

    Report Number
    1035160-1997-00009
    Event Type
    Other
    Date Received
    August 22, 1997
    Report Date
    July 16, 1997
    Manufacturer
    MAXXIM MEDICAL
    Product Code
    LRO
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    SCRUB NURSE DEVELOPED RASH ON ARMS AND AT NECKLINE AFTER HOSP INITIATED USE OF A NONWOVEN DISPOSABLE GOWN. THIS GOWN IS CONTAINED IN CUSTOM PROCEDURE PACKS SUPPLIED BY MAXXIM MED. THE EMPLOYEE HLTH NURSE INDICATED THAT THE ONE EMPLOYEE THAT EXPERIENCED THIS REACTION WAS PLACED BACK INTO A COTTON GOWN. NO ADD'L ACTIONS WERE REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXXIM MEDICAL CUSTOM PROCEDURE TRAY LRO MAXXIM MEDICAL 6171079 59

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other