BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 505954 · Received January 6, 2004

    Report

    Report Number
    505954
    Event Type
    Injury
    Date Received
    January 6, 2004
    Date of Event
    December 17, 2003
    Report Date
    January 5, 2004
    Manufacturer
    UNK
    Product Code
    GFJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT UNDERGOING TOTAL KNEE REPLACEMENT; MALLET USED CRACKED AND LEFT RESIDUE ON SURGEON'S GLOVES AND ASSISTANT'S GLOVES. OPERATIVE SITE IRRIGATED WITH COPIOUS AMOUNT OF IRRIGATION. CASE COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK UNK GFJ UNK UNK *

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention