BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUPUNCTURE NEEDLE

    MDR report key: 3122096 · Received May 16, 2013

    Report

    Report Number
    MW5030237
    Event Type
    Injury
    Date Received
    May 16, 2013
    Date of Event
    March 25, 2013
    Report Date
    May 11, 2013
    Product Code
    MQX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    A PT OF A PHYSICAL THERAPIST, (B)(6), PT, RECEIVED A PNEUMOTHORAX AFTER A DRY NEEDLING TREATMENT AND WAS HOSPITALIZED AT (B)(6) HOSPITAL ON (B)(6). TREATMENT FOR THE PNEUMOTHORAX WAS PROVIDED BY (B)(6), MD. PT PROVIDERS USE ACUPUNCTURE NEEDLES TO PERFORM AN ACUPUNCTURE TECHNIQUE CALLED DRY NEEDLING. THERE IS NO STANDARD TRAINING OR STATE REGISTRATION REQUIRED FOR PTS TO DO ACUPUNCTURE. THERE IS AN ACUPUNCTURE PRACTICE ACT, BUT PTS PERFORM THIS TECHNIQUE UNDER THEIR SCOPE WITHOUT REGISTRATION. IT IS UNK WHERE THIS PT WAS TRAINED. TRAINING MAY BE AS LITTLE AS 23 HOURS IN A CONTINUING EDUCATION COURSE WITH NO CLINICAL TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    217439 ACUPUNCTURE NEEDLE MQX

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Hospitalization| L