BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECEPT

    MDR report key: 124264 · Received September 26, 1997

    Report

    Report Number
    59995-1997-00001
    Event Type
    Malfunction
    Date Received
    September 26, 1997
    Date of Event
    October 24, 1996
    Report Date
    September 22, 1997
    Manufacturer
    GUANGZHOU FORTUNIQUE
    Product Code
    FYF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    COMPLAINTS OF IRRITATION AT AN IN-SERVE EVALUATION. PRIMARY SKIN IRRITATION STUDIES WERE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECEPT BOUFFANT CAP FYF GUANGZHOU FORTUNIQUE 66-2411 960523

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other