BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGICAL EARLOOP FACE MASKS

    MDR report key: 10436513 · Received August 20, 2020

    Report

    Report Number
    MW5096173
    Event Type
    Injury
    Date Received
    August 20, 2020
    Date of Event
    July 31, 2020
    Report Date
    August 19, 2020
    Manufacturer
    AMD MEDICOM, INC.
    Product Code
    FXX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    VET TECHNICIAN USED A MASK, HAD DRY ITCHY SENSATION AROUND HER EYES. CONTINUOUSLY GOT WORSE THROUGHOUT THE WEEKS AND EVENTUALLY GOT SO BAD AROUND 3 WEEKS LATER THAT HER RIGHT EYE WAS SHUT. WENT TO URGENT CARE AND WAS GIVEN STEROID INJECTION, ANTIBIOTICS AND ANTIHISTAMINES. INFLAMMATION SUBSIDED AFTER INTERVENTION. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    899547 SURGICAL EARLOOP FACE MASKS MASK, SURGICAL FXX AMD MEDICOM, INC. (10)84370

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Hospitalization