MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-05 for FASCIABLASTER I'M NOT SURE. manufactured by Ashley Black/ Adb Interests, Llc.
[84990168]
Ordered fasciablaster and ran this device as directed across face in desire to slim and tone my skin. Also used on my stomach region and torso/ and a little along extremities. Used 2-5 times over course of about 3 weeks. I noticed eyelid drooping, aging of my face - skin loosening that i never had before. Also have had significant weight gain (about 8lbs) after use in short time frame and it continues to worsen - weight accumulating on belly (central obesity). Extreme fatigue occurred a few days immediately after use of device (had to stay in bed most of day) as well as diarrhea.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5071960 |
| MDR Report Key | 6843454 |
| Date Received | 2017-09-05 |
| Date of Report | 2017-08-24 |
| Date of Event | 2017-07-01 |
| Date Added to Maude | 2017-09-05 |
| 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 | FASCIABLASTER |
| Generic Name | COMPONENTS, EXERCISE |
| Product Code | IOD |
| Date Received | 2017-09-05 |
| Model Number | I'M NOT SURE. |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ASHLEY BLACK/ ADB INTERESTS, LLC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-09-05 |