MAUDE Adverse Event Report: ASHLEY BLACK SYSTEMS FASCIABLASTER

Device Problem Material Integrity Problem (2978)

Patient Problems Diarrhea (1811); Inflammation (1932); Anxiety (2328); Depression (2361); Weight Changes (2607)

Event Date 05/08/2017

Event Type  Injury  

Event Description

I began using (b)(6) fasciablaster in (b)(6) 2016 for pain relief. By (b)(6) 2016, i became very ill and started having digestive issues which began as diarrhea, then constipation and for 4 months this continued along with abdominal pain, bloating and horrendous gas. I started under a naturopath's care in (b)(6) and my bowel movements became loose and soft instead of diarrhea. In (b)(6) 2017, i couldn't take the digestive issues any longer and consulted with a gastroenterologist. I had a colonoscopy on (b)(6) and the findings from that were tortuous colon. The side effects were everything i described above. I spoke with a licensed massage therapist that evening and told her about my findings and the fasciablaster. Her reply to me was this "fascia connects skin to muscle and other tissues in your body. If you used it hard enough or often enough it could have irritated the ligaments that hold your intestines in the way they are supposed to be, to the point they gave up or had to move to protect the underlying organs. I would say that it isn't so far fetched to totally discredit that idea. " i had a colonoscopy in (b)(6) 2011 and there was no report of a tortuous colon. Also, of one point about 6-7 weeks ago, the pain in my hip and low back was so bad i could barely moved. I haven't used this device in over 4 weeks now and have no pain. I am waiting on results of cortisol tests, but the theory is this device has raised my cortisol levels increasing my inflammation, causing me to gain 15 pounds to date and 6 percentage points in body fat. Depression and anxiety were so bad 6-7 weeks ago that it interfered with my life. I have all of my hormone levels tested approx every 2 months and all levels have dropped. There have been no other changes in my life other than using the (b)(6) fasciablaster. I had this device at my home but rarely used it on myself, maybe averaging 1 every 2 weeks from (b)(6) 2016 - (b)(6) 2017. Once every 3-4 weeks beginning in (b)(6) 2016. I would pay my chiropractor to professionally use the device for an hour at a time on my legs, calves, hips back arms and abdomen.

• Brand Name: FASCIABLASTER
• Type of Device: FASCIABLASTER
• Manufacturer (Section D): ASHLEY BLACK SYSTEMS
• MDR Report Key: 6568604
• MDR Text Key: 75360093
• Report Number: MW5069783
• Device Sequence Number: 1
• Product Code: IOD
• 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: 05/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No Answer provided

Was the Report Sent to FDA?

• Event Location: No Information

Was Device Evaluated by Manufacturer?

Is the Device Single Use?

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage

Patient Treatment Data

Date Received: 05/13/2017 Patient Sequence Number: 1

Treatment

1 PACKET 2XDAY; 1 WITH LUNCH; 1 WITH LUNCH; 1 WITH LUNCH; 1 WITH LUNCH ; 1 X DAY; 2 AT LUNCH ; 2 WITH BREAKFAST; 2 WITH DINNER ; APEX ENERGETICS CLEARVITE-GL 1 SCOOP 2XDAY; APEX ENERGETICS ENTEROVITE 2 WITH EACH MEAL; APEX ENERGETICS ENZYMIX PRO 2 PER MEAL ; APEX ENERGETICS METHYL-SP 1 WITH BREAKFAST,; APEX ENERGETICS STRENGTIA PROBIOTICS 1 BEFORE; BEDTIME; BEDTIME; BEFORE BEDTIME; BIOGENESIS ADRENAL SUPPORT PLUS 2 WITH BREAKFAST,; BIOTICS RESEARCH BIO ASHWAGANDA 1-2 AT BEDTIME; BIOTICS RESEARCH CORP 5 HTP 1 AT DINNER; BIOTICS RESEARCH IPS 2 WITH BREAKFAST, ; BIOTICS RESEARCH THYROSTIM 2 WITH BREAKFAST, ; BREAKFAST, 1 BEFORE BEDTIME; COMPLIMED QUIETIVA 16 DROPS UNDER TORQUE AT ; COMPOUNDED BI-EST 1.1MG PER DAY; COMPOUNDED PROGESTERONE 200MG PER DAY; COMPOUNDED TESTOSTERONE .3MG PER DAY; DESIGNS FOR HEALTH HISTAEZE 2 WITH LUNCH AND; DESIGNS FOR HEALTH NEUROCALM 1 PER MEAL; DESIGNS FOR HEALTH WATER EASE 3 WITH BREAKFAST; DESIGNS FOR HEALTH WEIGHT LOSS SUPPORT PACKETS ; DHEA SR 50MG CAPSULE EVERY OTHER DAY; NATURE'S SUNSHINE SILVER SHIELD 1.5 TEASPOONS ; NATURETHROID 16.25MG 1 EACH PER DAY; NATURETHROID 65MG AND; NORDIC NATURALS PROOMEGA CRP 4 WITH DINNER; NUMEDICA GLUTENZA 1 WITH EACH MEAL OUT. ; NUMEDICA MELATONIN 2 DROPPERS FULL AT BEDTIME; NUMEDICA MINERALPLEX 2 AT BREAKFAST, ; NUTRAMEDIX VERMELLA SLIM 6 DROPS 2XDAY; NUTRIWEST #14 LB-CLN 1 AT BEDTIME; NUTRIWEST ADRENOLYPH 160 2 WITH BREAKFAST, ; NUTRIWEST ASPARTICCHROME 1 PER MEAL ; QUICKSILVER SCIENTIFIC LIPOSOMAL GABA 4-6 PUMPS AT; REGENRX ADRENAL 10 DROPS UNDER TONGUE 2X/ DAY; SIMILSAN ANXIETY RELIEF 4-7 AT BEDTIME AT NEEDED; SYSTEMIC FORMULAS CX3 10 DROPS 2XDAY; VITAL NUTRIENTS PANCREATIN&OX BILE EXTRACT -; XYMOGEN D3 LIQUID 7 DROPS AT BEDTIME; XYMOGEN OPTIMAG NEURO 1.5 SCOOPS IN WATER