BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCL SPLINT ROLL

    MDR report key: 348388 · Received August 21, 2001

    Report

    Report Number
    1928508-2001-00002
    Event Type
    Injury
    Date Received
    August 21, 2001
    Date of Event
    July 1, 2001
    Report Date
    August 16, 2001
    Manufacturer
    M-PACT WORLDWIDE MGMT. CORP.
    Product Code
    LGH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    SECOND DEGREE BURNS ALONG SEAM OF SPLINT ON FOREARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38129 OCL SPLINT ROLL PLASTER SPLINT LGH M-PACT WORLDWIDE MGMT. CORP. SR615 NR

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention TRAY AND PAD (2001 TO 2001 (STOP'D)).