MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-27 for ASHLEY BLACK FASCIA BLASTER manufactured by Ashley Black Fascia Blaster / Adb Interests, Llc.
[96027402]
I used ashley black fascia blaster on stomach scar. Within hours i became severely depressed. Like catatonic depression not realizing i continued for a couple of weeks. I fell so deep into depression. I was unable to leave my bed for months. I also experienced severe anxiety, memory loss. I just wanted to die. I had no idea it was related to blasting. I stopped blasting for whatever reason. I began blasting again in (b)(6), this time on a scar that runs along my hairline. Later that night i was a fetal position again crying uncontrollably for hours. I am still experiencing crying, ruminating, anxiety and memory problems and stomach pains. I texted my sister to tell her how depressed i was. She has immediately made the connection.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5074263 |
| MDR Report Key | 7150586 |
| Date Received | 2017-12-27 |
| Date of Report | 2017-02-24 |
| Date of Event | 2017-02-01 |
| Date Added to Maude | 2017-12-28 |
| 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 | ASHLEY BLACK FASCIA BLASTER |
| Generic Name | COMPONENTS, EXERCIZE |
| Product Code | IOD |
| Date Received | 2017-12-27 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ASHLEY BLACK FASCIA BLASTER / ADB INTERESTS, LLC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Other; 3. Required No Informationntervention; 4. Deathisabilit | 2017-12-27 |