BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA-SPLINT SYNTH RL 4"X15FT

    MDR report key: 477552 · Received August 13, 2003

    Report

    Report Number
    1818910-2003-00530
    Event Type
    Injury
    Date Received
    August 13, 2003
    Date of Event
    July 18, 2003
    Report Date
    July 18, 2003
    Manufacturer
    DEPUY-NORTH BRUNSWICK, CASTING PRODUCTS DIVISION
    Product Code
    FYH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT SUFFERED FROM MACERATION 3 DAYS AFTER APPLICATION OF THE DELTA SPLINT TONGUETTE. THE USER NOTICED THAT THE HUMIDITY USED TO ACTIVATE THE LONGUETTE STILL WAS NOT EVAPORATED ON THE 3RD DAY, SO THAT THE LONGUETTE STILL WAS VERY WET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DELTA-SPLINT SYNTH RL 4"X15FT CASTING PRODUCTS FYH DEPUY-NORTH BRUNSWICK, CASTING PRODUCTS DIVISION NA 1141

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention