MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-29 for VELASHAPE manufactured by Syneron.
[25012342]
I had velashape by syneron performed for 1/2 hour on the back sides of my upper legs. Operator said, drink lots of water afterwards, to remove toxins. Driving home, my stomach got queasy, and got worse as the day progressed. Next day, i got a hemorrhoid (never before had them). Next few days, i got several hemorrhoids. I am thin, athletic, 5'5", (b)(6) cauc female, bp avg 112/69, always soft, thin stools. I do not eat out, and have a very limited diet, the only change being the sealed water bottle given by practitioner. The operator said syneron said this is not a possible symptom. Well, i know it is what caused my excruciatingly painful symptoms. So i am now reporting it.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5055890 |
| MDR Report Key | 5053496 |
| Date Received | 2015-08-29 |
| Date of Report | 2015-08-29 |
| Date of Event | 2015-08-20 |
| Date Added to Maude | 2015-09-03 |
| 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 | 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 | VELASHAPE |
| Generic Name | VELASHAPE |
| Product Code | NUV |
| Date Received | 2015-08-29 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNERON |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-08-29 |