BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTINUOUS POSITIVE AIRWAY PRESSURE MACHINE CPAP

    MDR report key: 12043287 · Received June 22, 2021

    Report

    Report Number
    MW5102013
    Event Type
    Injury
    Date Received
    June 22, 2021
    Date of Event
    March 20, 2019
    Report Date
    June 20, 2021
    Manufacturer
    UNK
    Product Code
    QBY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    TRIGGERED MST NIGHT TERRORS; THE (B)(6) ON (B)(6) IGNORED MY REPEATED REPORTS THAT THE CPAP MACHINE THEY ISSUED ME TRIGGERED MILITARY SEXUAL TRAUMA NIGHT TERRORS, PHYSICAL PAIN, INSOMNIA, ANXIETY, ACID REFLUX, ETC. THEY ALSO DISMISSED MY REQUESTED FOR ACCOMMODATIONS UNDER THE AMERICANS WITH DISABILITIES ACT ON MULTIPLE OCCASIONS AND DISMISSED MY REQUESTS TO PROVIDE COMMUNITY CARE APPOINTMENTS THAT WERE CLOSE TO WHERE I LIVE TO ACCOMMODATE MY TRAFFIC ANXIETY. THEY MADE APPOINTMENTS FOR ME THAT WERE 45 MINUTE OR MORE DRIVE AWAY DURING LITTLE /LIGHT TRAFFIC AND ONE APPOINTMENTS FOR A MANDIBULAR DEVICE WAS SET FOR 78 MILES AWAY FROM MY HOME ON A ROUTE THAT FREQUENTLY HAD HIGH TRAFFIC AND RUN WORK CAUSING DRIVE TIMES TO BE HIGH ALL WHILE I WAS ACTIVELY HAVING TRAFFIC ANXIETY, BACK AND HIP PAIN, INSOMNIA, NIGHT TERRORS, CLENCHING OF MY JAW, GRINDING OF MY TEETH AND ACID REFLUX FROM MILITARY SEXUAL TRAUMA TRIGGERS. THE (B)(6) HAS SEVERELY IMPACTED MY MENTAL AND PHYSICAL HEALTH AND INCREASED MY THOUGHTS OF SUICIDE. THEY ARE DISMISSIVE AND NEGLECTFUL. MY BODY NOW GOES INTO SEVERE DYSREGULATION INTERACTING WITH ANY COMPONENT OF THE VETERAN'S ADMINISTRATION. I HAVE REPEATEDLY CONTACTED THE (B)(6) SECRETARY VIA EMAIL AND CALLED THE (B)(6) HOTLINE. I NOW FEAR SEEKING MEDICAL CARE AND CANNOT ADHERE TO THE MASK MANDATES BECAUSE IT TRIGGERS MILITARY SEXUAL TRAUMA PHYSICAL AND MENTAL SYMPTOMS. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    936553 CONTINUOUS POSITIVE AIRWAY PRESSURE MACHINE CPAP POSITIVE AIRWAY PRESSURE SYSTEM QBY UNK UNK
    936554 MASK FACE MASK PER ENFORCEMENT POLICY FOR FACE MASKS AND RESPIRATORS DURING THE COVID QKR UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Life Threatening| O| R ALEVE