MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-10 for FASCIABLASTER FACE BLASTER manufactured by Ashley Black/ Adb Interests, Llc.
[108135734]
I started a year ago using the fasciablaster face blaster on my neck area under my chin about 3 times a week for many months. About two weeks ago i noticed a large lump under my chin. I have discontinued using the blaster and sent it back and am now awaiting more testing on the lump. This is an unsafe product.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5077139 |
| MDR Report Key | 7506278 |
| Date Received | 2018-05-10 |
| Date of Report | 2018-05-08 |
| Date of Event | 2018-04-25 |
| Date Added to Maude | 2018-05-11 |
| 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 FACE BLASTER |
| Generic Name | COMPONENTS, EXERCISE |
| Product Code | IOD |
| Date Received | 2018-05-10 |
| 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. Required No Informationntervention; 2. Deathisabilit | 2018-05-10 |