MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-07-06 for LASER manufactured by .
[3570647]
On (b)(6) 2013, i signed up for laser lipo treatments at (b)(6). I was signed up with the promise of weight loss and fat reduction through the use of external lasers. These unlicensed lasers are not safe. They cause dizziness and headaches after use. I completed 8 treatments and i have not lost any fat or weight. This service is a scam. I am seeking a 100% refund in the amount of (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5030822 |
| MDR Report Key | 3221732 |
| Date Received | 2013-07-06 |
| Date of Report | 2013-07-06 |
| Date of Event | 2013-07-01 |
| Date Added to Maude | 2013-07-15 |
| 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 |
| Generic Name | LASER |
| Product Code | OLI |
| Date Received | 2013-07-06 |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-07-06 |