BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOLDEX

    MDR report key: 10487720 · Received September 2, 2020

    Report

    Report Number
    MW5096408
    Event Type
    Injury
    Date Received
    September 2, 2020
    Date of Event
    September 1, 2020
    Report Date
    September 1, 2020
    Manufacturer
    MOLDEX/METRIC, INC.
    Product Code
    MSH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    CRNA USING REPROCESSED MASK FROM (B)(6). BECAME SHORT OF BREATH AND UNABLE TO BREATHE WHEN WEARING REPROCESSED MASK. NEW MASK GIVEN, NO FURTHER PROBLEMS REPORTED. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    950613 MOLDEX RESPIRATOR, SURGICAL MSH MOLDEX/METRIC, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other