FASCIA BLASTER

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-20 for FASCIA BLASTER manufactured by Ashley Black/ Panalpina / Abd Interests, Llc.

Event Text Entries

[87155075] Bought the fascia blaster (b)(6) 2017 as it was advertised to help with pain. Was at the time having lower back pain for 10 months. Started using the 3 fascia blasters and only used light and 1-3 minutes per area. Never went to a pain level of 7 as (b)(6) recommended. Started reading online about how the owner (b)(6) suddenly changed terms and conditions to include that the fascia blaster can cause weight gain, inflammation, etc and that the fascia blaster has bpa in it. Also started reading about women claiming injury from use of the fascia blaster and a variety of health complaints. These women claimed that (b)(6) deleted their reviews and told them their health injuries were not related to using the fascia blaster. After reading of all this, i felt the risk was not worth it. After using this product for only 3 weeks. I returned all 3 fascia blasters, oils, etc at the end of (b)(6) 2017 and received a refund minus shipping. Approx 7 days after i stopped using the fascia blaster, strange symptoms started. The first diagnosis was a pinched nerve-cervical in (b)(6) 2017. The 2nd condition was a burst blood vessel in my iliopsoas muscle and internal bleeding into my pelvis on (b)(6) 2017. A (b)(6) hospital visit to my md resulted in my md's notification to me that the fascia blaster caused both health conditions and that i was to never use again.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5072251
MDR Report Key6883184
Date Received2017-09-20
Date of Report2017-09-19
Date of Event2017-07-17
Date Added to Maude2017-09-21
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 NameFASCIA BLASTER
Generic NameFASCIA BLASTER
Product CodeIOD
Date Received2017-09-20
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerASHLEY BLACK/ PANALPINA / ABD INTERESTS, LLC


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization 2017-09-20

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