MAUDE Adverse Event Report: ADB INTEREST, LLC ASHLEY BLACK GURU FASCIABLASTER ; MASSAGER, THERAPEUTIC, MANUAL

Device Problem Break (1069)

Patient Problems Malaise (2359); Weight Changes (2607); No Code Available (3191)

Event Date 12/01/2017

Event Type  Injury  

Event Description

I bought the fasciablaster from ashley black company in 10/2016, i followed her recommended protocols and watched her videos, against all odds i started feeling sick and gained weight, my menstrual period became crazy out of the charts, she claimed it was the "worst before better stage" but by late (b)(6) i noticed a big bump in my back, kind of like on top of my scapula, i got it checked in (b)(6) 2018 and it was lipoma, i spoke with my doctor about the blaster and he thinks it could be related to that.I of course stopped using it and tried to save enough money for surgery to remove the lipoma, i still can't afford it.Then i learned about all the legal issues ms black is having, the false claims and the convenient (for them) changes in their protocols.I just learned that i can return the blaster, since it is under the 1000 days guarantee, but they refuse to give me a full refund of the (b)(6) dollars i spend buying the fasciablaster.I just want a full refund from the company.The fasciablaster was replaced because it broke but the last one i received broke too.I am attaching the photo.Date the person first started taking or using the product: (b)(6) 2016.Date the person stopped taking or using the product: (b)(6) 2017.Did the problem stop after the person reduced the dose or stopped taking or using the product? fda safety report id # (b)(4).

• Brand Name: ASHLEY BLACK GURU FASCIABLASTER
• Type of Device: MASSAGER, THERAPEUTIC, MANUAL
• Manufacturer (Section D): ADB INTEREST, LLC
• MDR Report Key: 8550704
• MDR Text Key: 143291620
• Report Number: MW5086163
• Device Sequence Number: 1
• Product Code: LYG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 38 YR
• Patient Weight: 82