BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MDF

    MDR report key: 22923320 · Received August 29, 2025

    Report

    Report Number
    3015989011-2025-00009
    Event Type
    Malfunction
    Date Received
    August 29, 2025
    Date of Event
    August 27, 2025
    Report Date
    August 28, 2025
    Manufacturer
    MDF INSTRUMENTS CRAFTECH LLC
    Product Code
    FZY
    UDI-DI
    06940211613016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER SERVICE WILL CONTACT THE CUSTOMER BY AMAZON BUYER MESSAGES AND REQUEST THE SERIAL NUMBER, LOT NUMBER, OR A PICTURE OF THE INSTRUMENT. THIS INFORMATION IS NEEDED FOR SHANGHAI TO BEGIN A RECORD REVIEW FOR THIS NON-CONFORMANCE.

    Description of Event or Problem · 0

    IT WAS REPORTED: "POINTED TIP WAS UNEVEN AND CAUSED UNINTENDED SKIN IRRITATION RATHER THAN ELICITING PRECISE REFLEX RESPONSES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2163260 MDF BABINSKI REFLEX HAMMER WITH POINTED TIP FZY MDF INSTRUMENTS CRAFTECH LLC MDF535 UNKNOWN 06940211613016

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female