BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CPAP CONTINUOUS POSITIVE AIRWAY PRESSURE HEADGEAR

    MDR report key: 7864485 · Received September 10, 2018

    Report

    Report Number
    MW5079696
    Event Type
    Injury
    Date Received
    September 10, 2018
    Date of Event
    July 3, 2018
    Report Date
    September 10, 2018
    Manufacturer
    3B MEDICAL INC.
    Product Code
    BZD
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAVE A PRESCRIPTION FOR A CPAP MACHINE FOR SLEEP APNEA. IT IS NOTED IN ALL MY MEDICAL RECORDS I AM ALLERGIC TO NEOPRENE. THE FIRST TWO HEADGEAR UNITS HAD NEOPRENE. I HAD A MODERATE / COULD HAVE BEEN SEVERE IF I HAVE NOT NOTICED MY ALLERGIC REACTION. I AM UNABLE TO FIND A HEADGEAR UNIT WITHOUT NEOPRENE. NO HEADGEAR UNIT HAS BEEN MADE WITH MATERIAL TOP. IF I GO TO A PHARMACY, THEY WILL FLAG A MEDICATION I AM ALLERGIC TO. THE SAME SAFETY CONCERN APPARENTLY DOES NOT APPLY WITH DURABLE MEDICAL EQUIPMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703882 CPAP CONTINUOUS POSITIVE AIRWAY PRESSURE HEADGEAR VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD 3B MEDICAL INC. ELARA FULL FACE MASK

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention