BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    K-WIRE 1.1, 100MM

    MDR report key: 12682014 · Received October 22, 2021

    Report

    Report Number
    2031009-2021-00005
    Event Type
    Malfunction
    Date Received
    October 22, 2021
    Date of Event
    September 22, 2021
    Report Date
    October 22, 2021
    Manufacturer
    TRIMED INC
    Product Code
    NDL
    UDI-DI
    00842188109331
    PMA / PMN Number
    K951303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    TRIMED INC ((B)(4)) PLANS TO SEND THE CORRECT LABELS TO TRIMED (B)(4) WHERE TRIMED (B)(4) WILL TAKE OFF THE INCORRECT LABEL AND REPLACE WITH THE APPROPRIATE LABEL. TRIMED (B)(4) IS TRIMED INC IN (B)(4) IMPORTER/ DISTRIBUTOR FOR EUROPE.

    Description of Event or Problem · 0

    TRIMED (B)(4) (AN IMPORTER / DISTRIBUTOR FOR TRIMED INC) STATED ON (B)(6) 2021 THAT 150 (30 TUBES OF 5 EACH) WIRE-1.1/100 DEVICES WERE LABELED FOR THE WIRE-0.7/080. THIS IS PRODUCT MISLABELED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1584026 K-WIRE 1.1, 100MM K-WIRE 1.1, 100MM NDL TRIMED INC WIRE-1.1/100 90598 00842188109331

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other