MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-05-16 for ACUPUNCTURE NEEDLE manufactured by .
[3567157]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5030237 |
| MDR Report Key | 3122096 |
| Date Received | 2013-05-16 |
| Date of Report | 2013-05-11 |
| Date of Event | 2013-03-25 |
| Date Added to Maude | 2013-05-22 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | ACUPUNCTURE NEEDLE |
| Product Code | MQX |
| Date Received | 2013-05-16 |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening | 2013-05-16 |