FASCIABLASTER

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-18 for FASCIABLASTER manufactured by Ashley Black/adb Interests.

Event Text Entries

[86764094] I started blasting in (b)(6) 2016, then in (b)(6) of this year my entire body was covered in a horrible case of hives! I was literally covered from my head to my wrists and ankles and it lasted for over a month and itched/burned constantly! I was miserable! I found out that it was due to inflammation from my body reacting to the damage the blaster was doing to my body. I was seen twice by my pcp. The first appointment, he gave me a steroid shot to try to get rid of the hives but after a week, there was no improvement. The second appointment, i was given a steroid pack that relieved my symptoms on day three of taking them but the day after i finished the 5 day pack, the hives came back even worse. After more than a month, i was finally able to get some relief with a product from the natural food market. I stopped blasting when the hives appeared, and during the month i wasn't blasting, i noticed that several areas of my body but most noticeably, my thighs and knees are literally covered in cellulite and now have odd indented areas. But before i started blasting, those were one of my favorite areas of my body. I'd wear shorts every chance i could, i avoid them now. The only reason i ever blasted them was because according to (b)(4), they were "beyond bound". I also gained 15 pounds while i was blasting.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5072206
MDR Report Key6876009
Date Received2017-09-18
Date of Report2017-09-16
Date of Event2017-04-15
Date Added to Maude2017-09-19
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
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 Received2017-09-18
Lot Number2.0 092116
OperatorLAY USER/PATIENT
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerASHLEY BLACK/ADB INTERESTS


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2017-09-18

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.