FASCIABLASTER

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-04 for FASCIABLASTER manufactured by Adb Interests, Llc.

Event Text Entries

[110220284] Cortisol and estrogen and progesterone went haywire from the ashley black fasciablaster stick along with getting a bulging disc in my l4, l5 and s1 from blasting to her protocols to get rid of right fascia and muscles. She would say blast up to a pain level of 7 and encouraging bruising as a good thing. Her protocols have since changed but at the time thousands of us were given the first set of protocols. This caused harm to my spine after just blasting to a pain level of 4 or 5. She constantly contradicts herself and bullies people that want to share their story of their adverse reactions and deletes negative questions or comments on her (b)(6) page. Now that she is getting sued in two class action lawsuits, she now allows a few of the comments. I also put on 20 lbs from the detoxing and inflammation and as a fitness instructor i never had any issues with pain, bloating, inflammation or weight prior to blasting. Please help us and please make her accountable for her business practices.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5077622
• MDR Report Key: 7568741
• Date Received: 2018-06-04
• Date of Report: 2018-06-03
• Date of Event: 2017-04-15
• Date Added to Maude: 2018-06-05
• 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

Device Details

• Brand Name: FASCIABLASTER
• Generic Name: COMPONENTS, EXERCISE
• Product Code: IOD
• Date Received: 2018-06-04
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ADB INTERESTS, LLC

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention; 2. Deathisabilit	2018-06-04