BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEIRIN J-TYPE ACUPUNCTURE NEEDLES

    MDR report key: 21306710 · Received February 4, 2025

    Report

    Report Number
    1000120741-2025-00001
    Event Type
    Injury
    Date Received
    February 4, 2025
    Date of Event
    December 6, 2024
    Report Date
    February 4, 2025
    Manufacturer
    SEIRIN CORPORATION
    Product Code
    MQX
    UDI-DI
    04547248701246
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SEIRIN J-TYPE NO.3 (DIA0.20)×60MM ACUPUNCTURE NEEDLES WERE USED DURING THE ACUPUNCTURE TREATMENT. AFTER 5-10 MINUTES OF TREATMENT, WHEN THE ACUPUNCTURIST REMOVED THE NEEDLES, ONE TOP OF THE NEEDLE WAS FOUND TO HAVE REMAINED INSIDE THE BODY OF THE PATIENT. AT THIS MOMENT, THE TOP OF THE NEEDLE, AS WELL AS THE REMOVED NEEDLE SHAFT, HAVE NOT BEEN PROVIDED YET FOR EXAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1094439 SEIRIN J-TYPE ACUPUNCTURE NEEDLES ACUPUNCTURE NEEDLE MQX SEIRIN CORPORATION J-TYPE NO.3(0.20)×60MM 24513G7 04547248701246

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention