MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-08 for BROAD BAND LIGHT/ BBL manufactured by Sciton, Inc..
[107841324]
I had cosmetic laser bbl by sciton on (b)(6) 2017. It was performed by an esthetician at (b)(6). About 10 days later i noticed fat loss from my right cheekbone area and fat loss from my lower cheek on the left side. Both cheeks have deflated but it is uneven, the shrinkage/ fat loss continued for about a month.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5077082 |
| MDR Report Key | 7498392 |
| Date Received | 2018-05-08 |
| Date of Report | 2018-05-06 |
| Date of Event | 2017-11-14 |
| Date Added to Maude | 2018-05-09 |
| 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 | BROAD BAND LIGHT/ BBL |
| Generic Name | LASER ASSISTED LIPOLYSIS |
| Product Code | ORK |
| Date Received | 2018-05-08 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SCITON, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-05-08 |