MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-09-25 for VELASHAPE manufactured by .
[21755748]
After 1 velashape treatment, had gurgling whoosh in my abdomen that night, felt fine otherwise. After 2nd visit, i began putting weight on in my abdomen. Thinking it was just a fluke change, i went to my third visit. Again, i put on weight. Concerned, i met with staff before final treatment. Was told that i was probably sluggish in my gi tract and it is unrelated except that the treatment was probably eliminating faster than my body was. It was suggested that i go ahead with my 4th and final treatment. I did. I'm bigger than ever and very concerned. Dates of use: (b)(6) 2012. Reason for use: couldn't get rid of fat pouch after babies. Event reappeared after reintroduction: yes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5027052 |
| MDR Report Key | 2765648 |
| Date Received | 2012-09-25 |
| Date of Report | 2012-09-15 |
| Date Added to Maude | 2012-10-01 |
| 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 | VELASHAPE |
| Generic Name | VELASHAPE |
| Product Code | NUV |
| Date Received | 2012-09-25 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-09-25 |