BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COACH

    MDR report key: 149955 · Received December 31, 1997

    Report

    Report Number
    MW4002128
    Event Type
    Injury
    Date Received
    December 31, 1997
    Date of Event
    December 15, 1997
    Report Date
    December 31, 1997
    Manufacturer
    DHD DIEMOLDING HEALTHCARE
    Product Code
    BWF
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    LATEX ALLERGY IN HOSP FROM INCENTIVE SPIROMETER. RPTR USED THE DHD (DIEMOLDING HEALTHCARE DIV) "COACH" INCENTIVE SPIROMETER. RPTR BREATHED IN AND TASTED LATEX FROM THE HOSE. 48 HRS LATER RPTR HAD SEVERE BLISTERS AROUND THEIR MOUTH, INTO THEIR NOSE AND SINUS CAVITIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COACH INCENTIVE SPIROMETER BWF DHD DIEMOLDING HEALTHCARE DHD 22-4000 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR