BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLY LAM PRODUCTS

    MDR report key: 26425 · Received August 31, 1995

    Report

    Report Number
    2243621-1995-00676
    Event Type
    Injury
    Date Received
    August 31, 1995
    Date of Event
    July 19, 1995
    Report Date
    August 15, 1995
    Manufacturer
    POLY LAM PRODUCTS
    Product Code
    FKG
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PRODUCT IS ALLERGENIC. RN STATES PRODUCT CAUSED DIFFICULTY IN BREATHING AND LUNG PAIN TO A TOTAL OF 3 EMPLOYEES. EMPLOYEES REPORTED TO BE WITHOUT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLY LAM PRODUCTS DRIMOP-SUPERABSORBENT FKG POLY LAM PRODUCTS 95035

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention