BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PFR95 RESPIRATOR

    MDR report key: 95329 · Received May 28, 1997

    Report

    Report Number
    1625443-1997-00003
    Event Type
    Malfunction
    Date Received
    May 28, 1997
    Date of Event
    February 27, 1997
    Report Date
    May 28, 1997
    Manufacturer
    TECNOL MEDICAL PRODUCTS, INC.
    Product Code
    FXX
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HEADBAND BROKE ON RESPIRATOR WHILE NURSE WEARING DEVICE WAS ASSESSING A PT WITH TUBERCULOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFR95 RESPIRATOR SURGICAL MASK/RESPIRATOR FXX TECNOL MEDICAL PRODUCTS, INC. PFR95-170 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN