MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-22 for VANQUISH manufactured by Btl Vanquish.
[27203626]
I had 2 treatments with btl vanquish (fat reducing device) in a doctor's office. I have severe radio frequency burns and 3 large hard lumps in my abdominal area. Going to a new doctor for help and relief as i have been in pain for 2 weeks and no relief in sight. The doctor's office that offers the procedure is not sure what has happened, but said it will go away. Two weeks have past and nothing has changed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5056629 |
| MDR Report Key | 5113814 |
| Date Received | 2015-09-22 |
| Date of Report | 2015-09-22 |
| Date of Event | 2015-09-08 |
| Date Added to Maude | 2015-09-30 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | VANQUISH |
| Generic Name | VANQUISH |
| Product Code | IMJ |
| Date Received | 2015-09-22 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | BTL VANQUISH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-09-22 |