FASCIABLASTER

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-06 for FASCIABLASTER manufactured by Ashley Black, Adb Production, Adb Interests, Llc.

Event Text Entries

[110534371] I bought ashley black guru fasciablaster in the 3 sizes available in late 2016 to early 2017. I used them regularly for 3 months following the instructions provided by abg in her book, videos, and websites. I paid special attention to my waist and stomach which were my problem areas. I stopped using the tools on my whole body in (b)(6) 2016 after seeing no positive results. Abg said that it could take 9 months for the fasciablasters to work but i decided that 3 was enough to see that the treatment wasn't going anywhere. However, i kept using the small face blaster around my ankles when they felt tired after a long day at work. In 2017 i started to put on weight, especially around my waist and on my stomach. I gained 5 inches in the area and ended up with a round belly. When i eventually went on a diet, my lower belly started to sag. I now have an overhang that starts from one hip and ends at the other. The sagginess appeared in the area where i rubbed the fascia blaster in a crisscross pattern to "carve the abs" as ashley black guru recommended. My ankles also started to bother me early in 2017. By (b)(6) they have become so weak and painful that i couldn't work standing for more than 30 minutes. They got so bad that i was considering early retirement. Then i found a (b)(6) group for women who experienced adverse effects from the use of ashley black guru's fasciablasters. One woman's testimonial described the same ankle issues as mine. I stopped "blasting" my ankles after that and my problems disappeared within one month. Now my ankles are back being strong, flexible and pain free. I'm back doing standing work for many hours at a time. In the same (b)(6) group i also read the stories of many women who put on weight after using the fasciablasters, especially around the waist and on their stomach. I found out from them that ashley black guru had added a long list of contraindications to her websites, which includes weight gain. Yet, when i bought her tools she advertised, that they helped users lose fat and lose weight without diet or exercise.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5077675
• MDR Report Key: 7577581
• Date Received: 2018-06-06
• Date of Report: 2018-06-05
• Date of Event: 2017-01-01
• Date Added to Maude: 2018-06-07
• 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

Device Sequence Number: 1

• Generic Name: FASCIABLASTER
• Product Code: IOD
• Date Received: 2018-06-06
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ASHLEY BLACK, ADB PRODUCTION, ADB INTERESTS, LLC

Device Sequence Number: 2

• Brand Name: MINI 2
• Generic Name: FASCIABLASTER
• Product Code: IOD
• Date Received: 2018-06-06
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: ASHLEY BLACK, ADB PRODUCTION, ADB INTERESTS, LLC

Device Sequence Number: 3

• Brand Name: FACE BLASTER
• Generic Name: FASCIABLASTER
• Product Code: IOD
• Date Received: 2018-06-06
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 3
• Device Event Key: 0
• Manufacturer: ASHLEY BLACK, ADB PRODUCTION, ADB INTERESTS, LLC

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Deathisabilit	2018-06-06