MAUDE Adverse Event Report: ACUPUNCTURE (FILIFORM) NEEDLE; ACUPUNCTURE NEEDLE

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Pneumothorax (2012)

Event Type  Injury  

Event Description

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.

• Brand Name: ACUPUNCTURE (FILIFORM) NEEDLE
• Type of Device: ACUPUNCTURE NEEDLE
• MDR Report Key: 5383935
• MDR Text Key: 36624027
• Report Number: MW5059517
• Device Sequence Number: 1
• Product Code: MQX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 30 YR
• Patient Weight: 68