FASCIABLASTER 2.0

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-07 for FASCIABLASTER 2.0 manufactured by Ashley Black Guru.

Event Text Entries

[82369879] Started using fasciablaster (b)(6) 2017. On (b)(6) 2017 i noticed pain in my right calf. It then became very painful and red and that's when i noticed a varicose vein. I have never had any previously. The vein and painful swelling went down after 3-4 days but my calf is now disfigured. I have my calf muscle then a lump and another deep crease indention. I always blasted lightly and timed at 2-3 minutes per section. Due to busy schedule i only blasted at max 2 times a week. I stopped blasting and didn't start back until approx. (b)(6) the painful varicose looking vein showed up again. I then took more pictures and noticed how crepe and sagging the skin was above both knees. I was doing crossfit previously until (b)(6) 2017. Foolishly, i blasted once again and was going to do the isolation exercises that (b)(6) recommends to try and improve the problem areas i now have. After the last blast in (b)(6) 2017, i decided the product wasn't for me. As of today (b)(6) 2017 my calf is still deformed looking and i have not been able to tighten the crepe loose skin above my knees.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5071442
• MDR Report Key: 6776672
• Date Received: 2017-08-07
• Date of Report: 2017-08-07
• Date of Event: 2017-05-09
• Date Added to Maude: 2017-08-09
• 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: EXERCISE COMPONENTS
• Product Code: IOD
• Date Received: 2017-08-07
• Model Number: 2.0
• Lot Number: 121516
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ASHLEY BLACK GURU

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2017-08-07