BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEIRIN ACUPUNCTURE NEEDLE

    MDR report key: 22484536 · Received July 11, 2025

    Report

    Report Number
    3003135788-2025-00001
    Event Type
    Injury
    Date Received
    July 11, 2025
    Date of Event
    December 6, 2024
    Report Date
    July 11, 2025
    Manufacturer
    SEIRIN CORPORATION
    Product Code
    MQX
    UDI-DI
    04547248701246
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ACTUAL PRODUCT WAS NOT AVAILABLE FOR RECOVERY OR INSPECTION. NO ABNORMALITIES WERE IDENTIFIED IN THE MANUFACTURING RECORDS. NO SIMILAR COMPLAINTS HAVE BEEN REPORTED FROM THE MARKET. DUE TO LIMITED COOPERATION FROM THE MEDICAL INSTITUTION, THE PMDA REPORT WAS CLOSED AS "DETAILS UNKNOWN." SINCE WE HAVE DETERMINED THAT THIS INCIDENT WAS NOT TO BE DEVICE-RELATED, NO RECALL OR CORRECTIVE ACTION IS NECESSARY.

    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 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 RETRIEVED YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    948968 SEIRIN ACUPUNCTURE NEEDLE 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