BEUDAMED
    FDA Adverse Event Other Summary report: N

    *

    MDR report key: 346239 · Received August 9, 2001

    Report

    Report Number
    346239
    Event Type
    Other
    Date Received
    August 9, 2001
    Date of Event
    July 12, 2001
    Report Date
    August 7, 2001
    Manufacturer
    JARIT
    Product Code
    GZT
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING BUNIONECTOMY, PIECE OF MALLEABLE RETRACTOR WAS RETAINED. NOTED ON X-RAY AND REPORTED 08/03/2001. "DAVIS BRAIN SPATULA" BY JARIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36015 * MALLEABLE RETRACTOR GZT JARIT * *

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Other