BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLASTIC ISOLATION GOWN

    MDR report key: 19981713 · Received August 13, 2024

    Report

    Report Number
    MW5158400
    Event Type
    Injury
    Date Received
    August 13, 2024
    Report Date
    August 12, 2024
    Manufacturer
    MEDEGEN MEDICAL PRODUCTS
    Product Code
    OEA
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED (B)(6) TO MAKE A COMPLAINT REGARDING PRODUCT: 17-9991- 6 GOWN, PERS.PROT. UNIV.SIZE, BLUE#99916, THE PLASTIC CAUSES NAUSEA, HIGH BLOOD PRESSURE WILE IN THE HEAT WHILE TAKING CARE OF A PATIENT. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1619398 PLASTIC ISOLATION GOWN NON-SURGICAL ISOLATION GOWN OEA MEDEGEN MEDICAL PRODUCTS 99916

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown