FASCIABLASTER FASCIABLASTER AND FACE BLASTER

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-15 for FASCIABLASTER FASCIABLASTER AND FACE BLASTER manufactured by Adb Interests, Llc.

Event Text Entries

[108600209] I started using the fascia blaster in (b)(6) 2016. Following the prescribed protocols i was able to gain more flexibility in my knee that i had rehabbed after a torn acl. I believe the fascia blaster broke up the fascia aka scar tissue. I then bought more fascia blasters to use on my entire body, as on the fascia blaster's facebook page, many instructions were given and it was recommended that people "blast" their entire bodies as the fascia is all connected. The claim that cellulite would disappear was very enticing. I blasted as instructed and started gaining weight around my middle. Many people on the facebook page talked about detox symptoms as well as weight gain. The weight gain was attributed to the fact that your muscles were no longer bound by the "stuck" fascia, therefore you were building up your muscle tissue. As the months went on, i noticed the skin on my knees and abdomen had become stretched out and loose and saggy where it had previously been tight. According to (b)(6) you should be able to pull your skin away from your body in all areas, not just your hands and neck, but your thighs and calves. Whenever comments were made on the fasciablasting facebook group, women were told that there was a worse before better stage where your skin would become loose and saggy and then if you "trusted the process" and kept blasting, eventually your skin would lighten up again. So i kept blasting. When women asked how long this process took they were told it's different for everyone and then there would be photos posted of "before and after" results. I also noticed that i could now see cellulite on my upper arms where there had preteen none. One day a suggested facebook group came up on my facebook feed. There's a group that had formed about fasciablasting adverse effects. I joined the group and found out many women were having the same thing happen to them, with loose saggy skin, increased cellulite and some women even had much worse medical problems. When women asked questions bout negative effects on the main facebook group, they were continually told there were in the "worse before better" stage. Comments about actual medical issues were deleted or the person posting was told that their problem could not be attributed to the fasciablaster. I started telling women in the main group what had happened to me when i saw posts that were similar to what happened to me and then i received a couple of facebook messages from the fasciablaster admins asking me to send my photos to them and they would give me instructions to "fix" my fascia. I did not take them up on their requests. That too had ruined my skin, why would i believe continuing to use it would make it better. When women in the main group started asking to see "better after worse" photos the only photos that i ever saw were posted by the group, not any individuals. At this point, i discontinued use of the fascia blaster. I believe this product should be removed from the market. Women have had serious medical problems and though i'm grateful i did not have a serious medical issue, my skin will never be the same and i am not happy about that. Please help insure that no more people are hurt by this product that has had no medical studies done, is full of bpa and is being used by some (b)(6) fasciablaster fans on their children and animals. Thank you for letting me share what happened to me.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5077256
MDR Report Key7518276
Date Received2018-05-15
Date of Report2018-05-10
Date of Event2017-03-15
Date Added to Maude2018-05-16
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag0
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Sequence Number: 0

Brand NameFASCIABLASTER
Generic NameCOMPONENTS, EXERCISE FASCIABLASTER
Product CodeIOD
Date Received2018-05-15
Model NumberFASCIABLASTER AND FACE BLASTER
OperatorLAY USER/PATIENT
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No0
Device Event Key0
ManufacturerADB INTERESTS, LLC

Device Sequence Number: 1

Brand NameFASCIABLASTER
Generic NameCOMPONENTS, EXERCISE FASCIABLASTER
Product CodeIOD
Date Received2018-05-15
Model NumberFASCIABLASTER AND FACE BLASTER
OperatorLAY USER/PATIENT
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerABD INTERESTS, LLC


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2018-05-15

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