BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECEPT

    MDR report key: 124297 · Received September 26, 1997

    Report

    Report Number
    59995-1997-00002
    Event Type
    Malfunction
    Date Received
    September 26, 1997
    Date of Event
    November 14, 1996
    Report Date
    September 22, 1997
    Manufacturer
    GUANGZHOU FORTUNIQUE LIMITED
    Product Code
    FYF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    NURSE(S) EXPERIENCED FACIAL IRRITATION WHILE WEARING THIS BOUFFANT CAP.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other