FDA Adverse Event Injury Summary report: N

FASCIABLASTER ORIGINAL

MDR report key: 8424766 · Received March 14, 2019

Report

Report Number
MW5084925
Event Type
Injury
Date Received
March 14, 2019
Date of Event
March 23, 2017
Report Date
March 12, 2019
Manufacturer
ASHLEY BLACK GURU / ADB INTERESTS, LLC
Product Code
LYG
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
CT, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

I PURCHASED THE ORIGINAL FASCIABLASTER, THE MINI2 AND THE FACEBLASTER TO HELP ALLEVIATE SYMPTOMS ASSOCIATED WITH A DIAGNOSED AUTOIMMUNE DISORDER. MIXED CONNECTIVE TISSUE DISEASE. I USED ALL THREE OFF AND ON FOR LESS THAN A YEAR, FOLLOWING THE INSTRUCTIONS PROVIDED IN THE PACKAGING AS WELL AS THOSE PROVIDED IN (B)(6) VIDEO TUTORIALS. NOT ONLY DID IT NOT WORK TO ALLEVIATED MY PAIN, IT MADE IT WORSE AND ANY CELLULITE I HAD WORSENED AFTER EXTREME BRUISING. THE SKIN ON MY UPPER ARMS, INNER THIGHS, STOMACH AND ESPECIALLY MY NECK AREA IS NOW SAGGING AND CREEPY. I HAVE BEEN TOLD THAT THE ONLY WAY TO RESTORE THE SKIN ON MY NECK IS WITH A LOWER FACELIFT. WORSE THAN THAT, IT APPEARS THE USAGE OF THE FASCIABLASTER PRODUCTS CAUSED EARLY MENOPAUSE AT THE AGE OF (B)(6). I HAVE BEEN ON ESTROGEN AND PROGESTIN FOR TWO YEARS NOW AND BECAUSE OF A FAMILY HISTORY OF BREAST CANCER, I CAN ONLY BE ON THE LOWEST DOSAGE POSSIBLE AND MUST HAVE ROUTINE MAMMOGRAMS AND ULTRASOUNDS. I HAVE NOT HAD A MENSTRUAL CYCLE SINCE USING THE FASCIABLASTER. I RETURNED THE MINI2 FOR A REFUND, HOWEVER I COULD NOT RETURN THE FASCIABLASTER BECAUSE I COULD NOT FIND RECORD OF MY RECEIPT, AND THE COMPANY WOULD NOT ALLOW RETURNS ON THE FASCIABLASTER IF EVEN ONE OF THE OILS WAS OPENED, WHICH IT WAS. AFTER LEARNING OF SO MANY WOMEN BEING DAMAGED BY THESE PRODUCTS, I WANTED TO MAKE SURE I CAME FORWARD TO INCLUDE WHAT I'VE PERSONALLY EXPERIENCED IN THE HOPE THAT THE PRODUCTS ARE BANNED COMPLETELY. YOU ARE WELCOME TO CONTACT ME IF YOU NEED FURTHER INFO.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
212504 FASCIABLASTER ORIGINAL MASSAGER THERAPEUTIC, MANUAL LYG ASHLEY BLACK GURU / ADB INTERESTS, LLC
212505 MINI2 MASSAGER THERAPEUTIC, MANUAL LYG ASHLEY BLACK GURU / ADB INTERESTS, LLC
212506 FACEBLASTER MASSAGER THERAPEUTIC, MANUAL LYG ASHLEY BLACK GURU / ADB INTERESTS, LLC

Patients

Seq Age Sex Outcome Treatment
1 48 YR Required Intervention| S