BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEIRIN ACUPUNCTURE NEEDLES NO3 (.20) X 30 MM J TYPE

    MDR report key: 19416069 · Received May 28, 2024

    Report

    Report Number
    MW5155470
    Event Type
    Injury
    Date Received
    May 28, 2024
    Date of Event
    May 16, 2024
    Report Date
    May 22, 2024
    Manufacturer
    SEIRIN CORPORATION
    Product Code
    MQX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    OUTPATIENT PHYSICAL THERAPIST, CERTIFIED IN DRY NEEDLING, PERFORMED A DRY NEEDLING PROCEDURE AT THE R THORACIC PARASPINALS. DURING THE DRY NEEDLING SESSION, A 30MM DRY NEEDLE WAS INSERTED ALONG THE THORACIC SPINE AT A TRIGGER POINT LOCAL TO THE RIGHT THORACIC PARASPINALS. DURING THE NEEDLE IN AN ATTEMPT TO HAVE THE NEEDLE EXIT VIA THE PATH IT WAS INSERTED; THIS DID NOT OCCUR. THE PATIENT WAS THEN ESCORTED TO THE REST OF NEEDLES IN THAT BOX WAS REMOVED FROM PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1258523 SEIRIN ACUPUNCTURE NEEDLES NO3 (.20) X 30 MM J TYPE NEEDLE, ACUPUNCTURE, SINGLE USE MQX SEIRIN CORPORATION 22X09H8

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Male Required Intervention