FASCIABLASTER

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-14 for FASCIABLASTER manufactured by Ashley Black/adb Interests Llc.

Event Text Entries

[86460717] I started using the blaster in (b)(6) of 2016, as directed by the inventor ashley black. I used it for about 6 months. During that time i started to get major body aches and pains, off and on. I didn't think it was caused by blasting because i never saw any negative effects stated on her (b)(4) group. So i began to think i had lupus or even arthritis. I had test ran for but they came back negative. I still continued to blast until i stumbled across a group that were having negative effects and i stopped immediately. I started to question the effects in the (b)(4) group and got kicked out and blocked. I wasn't even able to leave a review on her "(b)(4)", because i was blocked there as well. Shortly after i stopped blasting, i started to break out with a rash that continued to get worse and worse. I took several trips to the dr, i ended up having to get a biopsy. The biopsy came back that i have mild chronic superficial perivascular dermatitis, due to inflammation of the blood vessels. My doctor believes this could have been done by blasting. I am now on steroids for 3 months. This has been the worst experience of my life. I have never had any other issues with my body or no pre existing conditions of any sort. Ashley black somehow learned of my injuries and unblocked me from her (b)(4). She also had someone from her company inbox me via (b)(4) messenger asking about my injuries and wanted me to show medical documents. At this point i didn't feel comfortable sharing that information with someone who has continuously lied and poke fun of injured customers.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5072158
MDR Report Key6868409
Date Received2017-09-14
Date of Report2017-09-13
Date of Event2017-06-01
Date Added to Maude2017-09-15
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 Details

Brand NameFASCIABLASTER
Generic NameCOMPONENTS, EXERCISE
Product CodeIOD
Date Received2017-09-14
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerASHLEY BLACK/ADB INTERESTS LLC


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2017-09-14

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