inforMED
InjuryLYG

FASCIABLASTER

Received Aug 20, 2019 · Event occurred Feb 11, 2018

Report MW5089211 · MDR key 8915554

Device

Generic name

Massager, Therapeutic, Manual

Manufacturer

Adb Interests, Llc

Model number

89-IOS AT 21

Lot number

CFR 8905350

Product problems

  • Adverse Event Without Identified Device or Use Problem

Patient

43 YR

  • Dysphagia/ Odynophagia
  • Menstrual Irregularities
  • Swelling
  • Dysphagia/ Odynophagia
  • Menstrual Irregularities
  • Swelling

Narrative

Description of Event or Problem

USED THE FASCIABLASTER AND MINIBLASTER ON MY LEG AND FACE AND NECK AS DIRECTED. NERVE ISSUES STARTED TO OCCUR. COULDN'T SWALLOW PROPERLY FOR MONTHS, LEFT LEG NERVE ISSUES NOTED BY NEUROLOGIST. WASN'T ABLE TO MOVE MY LEFT TOES. HAVE LUMPS UNDER SKIN THAT WERE NOT THERE BEFORE USING THE PRODUCT. INCREASED MENSTRUAL BLEEDING DURING USE OF DEVICES. FDA SAFETY REPORT ID # (B)(4).