BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXTRA-FAST PLASTER(GL) 5INX5YD

    MDR report key: 464176 · Received June 5, 2003

    Report

    Report Number
    1818910-2003-00328
    Event Type
    Injury
    Date Received
    June 5, 2003
    Date of Event
    May 2, 2003
    Report Date
    May 6, 2003
    Manufacturer
    DEPUY-NORTH BRUNSWICK/CASTINGS PRODUCTS DIVISION
    Product Code
    FYH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PLASTER MOLDING TECH ADVISES THE MOLD HAS GIVEN A PATIENT A 2ND DEGREE BURN. (THE MOLD IS MADE PRIOR TO FACILITATE THE MANUFACTURE OF A CUSTOMIZED SPLINT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTRA-FAST PLASTER(GL) 5INX5YD SPLINT; EXTREMITY FYH DEPUY-NORTH BRUNSWICK/CASTINGS PRODUCTS DIVISION NA 0173N002

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention