FASCIABLASTER

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-04 for FASCIABLASTER manufactured by Adb Interests, Llc.

Event Text Entries

[88246342] I purchased the fasciablaster from ashleyblackguru. Com in (b)(6) of 2016. I used the devices for 6 months and got very ill with chronic fatigue, gi issues, pain and my skin now is wrinkled in new places and i have cellulite where i had none before. Incident location: (b)(6), united states. This is my home address. The fasciablaster is advertised to cure cellulite, improve range of motion and lessen joint pain - i bought it for pain relief, then used it on my abdomen for aesthetic purposes. Product category: personal care. Retailer: ashleyblackguru. Com. Retailer state: (b)(6). Purchase date: (b)(6) 2016 this date is an estimate. I still have the product in my possession: no. The product was damaged before the incident: no. The product was modified before the incident: no. Have you contacted the manufacturer: yes. Explanation: i reached out to them several times in the 6 months i was using it, but never heard back from them.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5072591
• MDR Report Key: 6913986
• Date Received: 2017-10-04
• Date of Report: 2017-09-20
• Date of Event: 2017-04-24
• Date Added to Maude: 2017-10-04
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 0
• Product Problem Flag: 0
• 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: FASCIABLASTER
• Product Code: IOD
• Date Received: 2017-10-04
• Device Availability: *
• 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		2017-10-04