MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-01-14 for TIGER MOXA -YOUNG SHIN HEALTH manufactured by Young Shin Health, Llc.
[1318460]
The tiger moxa cauterer is extremely dangerous. It said that it should not contact the skin directly, however, it is real hot and burned skin. The moxa ash can be dropped and cause fire. Also, kit includes lancet which seemed like it's not fda approved. I thought that fda approved acupuncture and oriental medical devices. Apparently, it is not.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5014738 |
| MDR Report Key | 1604016 |
| Date Received | 2010-01-14 |
| Date of Report | 2010-01-14 |
| Date of Event | 2010-01-09 |
| Date Added to Maude | 2010-03-04 |
| 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 | PATIENT |
| 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 |
| Brand Name | TIGER MOXA -YOUNG SHIN HEALTH |
| Generic Name | TIGER MOXA |
| Product Code | MVV |
| Date Received | 2010-01-14 |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | YOUNG SHIN HEALTH, LLC |
| Manufacturer Address | SUWANEE GA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-01-14 |