BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECEPT

    MDR report key: 124293 · Received September 26, 1997

    Report

    Report Number
    59995-1997-00005
    Event Type
    Malfunction
    Date Received
    September 26, 1997
    Date of Event
    November 21, 1996
    Report Date
    September 22, 1997
    Manufacturer
    GUANGZHOU FORTUNIQUE LIMITED
    Product Code
    FYF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    NURSE(S) EXPERIENCED SLIGHT IRRITATION FROM THE ELASTIC AROUND THE BOUFFANT CAP. PRIOR PRIMARY SKIN IRRITATION STUDIES REFLECT THE ELASTIC TO BE NON-IRRITANT. NO SAMPLES OR LOT NUMBERS WERE AVAILABLE.

    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