BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AEROBIKA DEVICE

    MDR report key: 9967289 · Received April 15, 2020

    Report

    Report Number
    MW5094153
    Event Type
    Injury
    Date Received
    April 15, 2020
    Date of Event
    September 14, 2019
    Report Date
    April 14, 2020
    Manufacturer
    MONAGHAN MEDICAL CORP.
    Product Code
    BWF
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PT REPORTED PERIORAL NUMBNESS AFTER USING AEROBIKA DEVICE. NO LIP/ORAL SWELLING ON EXAM. NO OTHER SYMPTOMS. PT REPORTED RESOLUTION OF THE NUMBNESS APPROXIMATELY 15 MIN AFTER DIPHENHYDRAMINE. SYMPTOMS: PERIORAL NUMBNESS. TREATMENT DRUGS USED: 1- DIPHENHYDRAMINE (DIPHENHYDRAMINE HCL 50MG/ML INJ) DOSE: 25. UNITS: MG. FREQ: ONCE. ROUTE: IV. DATES OF USE: (B)(6) 2019. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED? YES. DIAGNOSIS FOR USE: PULMONARY TOILET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429542 AEROBIKA DEVICE SPIROMETER, THERAPEUTIC (INCENTIVE) BWF MONAGHAN MEDICAL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR