BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    B-D

    MDR report key: 2803252 · Received November 8, 2007

    Report

    Report Number
    2803252
    Event Type
    Malfunction
    Date Received
    November 8, 2007
    Date of Event
    October 12, 2007
    Report Date
    October 17, 2007
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING NEUROTOXIN INJECTION (BOTOX) FOR SPASM OF MUSCLE AND SPASTIC NONDOMINANT HEMIPLEGIA IN LEFT CALF MUSCLE, THE NEEDLE BROKE OFF AT THE HUB AND WAS EMBEDDED IN THE MUSCLE (CONFIRMED BY X-RAY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 B-D PRECISION GLIDE NEEDLE 27G1 1/4 FMF 305136

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR