MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2015-06-25 for PREMIO 10 MOXA - SEDATELEC manufactured by Sedatelec.
[21470303]
On (b)(6) 2015, a pt received moxibustion treatment with the device premio 10 moxa which was carried out by an acupuncturist. It has heated needles in the patient's knees. Following treatment, burns to the left and right knees were observed. On (b)(6) 2015, the pt met his family doctor and this one, at the state of the legs of the pt, requested a plastic surgery consultation. On (b)(6) 2015, the pt met a specialist and it confirmed second degree burns.
Patient Sequence No: 1, Text Type: D, B5
[21602113]
Premio 10 - moxa is indicated for temporary relief of minor muscle and joint pain, arthritis and muscle spasm, relieving stiffness, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation where heat is indicated.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8020802-2015-00001 |
| MDR Report Key | 4871931 |
| Report Source | 99 |
| Date Received | 2015-06-25 |
| Date of Report | 2015-06-24 |
| Date of Event | 2015-03-13 |
| Device Manufacturer Date | 2013-04-17 |
| Date Added to Maude | 2015-06-29 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | CHEMIN DES MURIERS |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PREMIO 10 MOXA - SEDATELEC |
| Generic Name | PREMIO 10 |
| Product Code | MQX |
| Date Received | 2015-06-25 |
| Catalog Number | PREMIO 10 MOXA |
| Lot Number | 2177 |
| Operator | HEALTH PROFESSIONAL |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SEDATELEC |
| Manufacturer Address | IRIGNY 69540 FR 69540 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2015-06-25 |