ACUPUNCTURE (FILIFORM) NEEDLE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-17 for ACUPUNCTURE (FILIFORM) NEEDLE manufactured by .

Event Text Entries

[36624027] A patient of a chiropractor in (b)(6) received a pneumothorax after a dry needling treatment in 2015. Chiropractors and physical therapists use acupuncture needles to perform a crude form of acupuncture called dry needling. After the dry needling treatment the patient experienced shortness of breath and chest pain and called the chiropractor expressing concern that she could not breathe. The patient was told by the chiropractor that she may be experiencing a muscle spasm in the chest area and advised her to do various stretches to try and alleviate the pain. Thirty minutes later the chiropractor called the patient back and told her to go to the emergency room that she may have punctured her lung. The patient was admitted to the emergency room and diagnosed with a pneumothorax.. The patient was also told by the chiropractor that her collapsed lung was the patient's fault since her muscle "inappropriately jumped" and drew the needle in further. The patient had been emotionally and physically traumatized since her dry needling experience. The patient expected that her health care provider be appropriately licensed in safety inserting needles into the tissues of the body. It is unknown where this practitioner was trained. An acupuncture practice act exists to maintain the highest credentials and skills needed to use acupuncture needles as regulated by the fda and licensed by (b)(6). This practice act is being bypassed by physical therapists and chiropractors with training that may be as little as 54 hours in (b)(6) in a continuing education course with non educational standards, no state registration, no board exams and no clinical time.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5059517
MDR Report Key5383935
Date Received2016-01-17
Date of Report2016-01-17
Date Added to Maude2016-01-21
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameACUPUNCTURE (FILIFORM) NEEDLE
Generic NameACUPUNCTURE NEEDLE
Product CodeMQX
Date Received2016-01-17
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
Manufacturer AddressUS


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Life Threatening 2016-01-17

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.