BEUDAMED
    FDA Adverse Event Injury Summary report: N

    J&J BARRIER EXTRA PROTECTION MASK

    MDR report key: 63594 · Received January 16, 1997

    Report

    Report Number
    1625443-1997-00002
    Event Type
    Injury
    Date Received
    January 16, 1997
    Date of Event
    December 17, 1996
    Report Date
    January 16, 1997
    Manufacturer
    TECHNOL MEDICAL PRODUCTS, INC.
    Product Code
    FXX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE RECEIVED BY MFR 1/6/97, FOLLOWING A TWO WEEK PLANT SHUTDOWN DURING THE CHRISTMAS AND NEW YEAR HOLIDAYS. THE INVESTIGATION IS NOT COMPLETE AT THIS TIME. ADD'L EVAL CODES WILL BE FORWARDED FOLLOWING COMPLETION OF INVESTIGATION. REMEDIAL ACTION TAKEN WILL BE INCLUDED IN ADD'L INFO REGARDING CONCLUSION OF INVESTIGATION. 2/21/97 ADD'LD INFO: ADD CONCLUSION CODE OF 60 TO H6. COMPLETE H7 WITH "ADD LABEL" TO PRODUCT TO INSTRUCT THE USERS OF THE MASK TO NOT REMOVE THE ANTI-FOG FILM. USER-INTER-FACE (REMOVING THE ANTI-FOG FILM) WEAKENS THE TOP BINDING SEAL AND THE NOSEPIECE MAY BECOME LOOSE FROM THE MASK.

    Description of Event or Problem · 1

    THE CONTACT REPORTED THAT ON OR SCRUB TECH WAS STRUCK IN THE EYE BY THE METAL NOSEPIECE OF THE MASK AS IT CAME THROUGH THE OUTER FACING OF THE MASK. THE WEARER WAS SEEN IN THE ER AND TREATED WITH ANTIBIOTICS. NO KNOWN LONG TERM OR PERMANENT DAMAGE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 J&J BARRIER EXTRA PROTECTION MASK MASK, SURGICAL FXX TECHNOL MEDICAL PRODUCTS, INC. NA 6K032228

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention