MAUDE Adverse Event Report: ADB INTERESTS, LLC FASCIABLASTER; MASSAGER, THERAPEUTIC, MANUAL

Model Number 89-IOS AT 21

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dysphagia/ Odynophagia (1815); Menstrual Irregularities (1959); Swelling (2091)

Event Date 02/11/2018

Event Type  Injury  

Event Description

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).

• Brand Name: FASCIABLASTER
• Type of Device: MASSAGER, THERAPEUTIC, MANUAL
• Manufacturer (Section D): ADB INTERESTS, LLC
• MDR Report Key: 8915554
• MDR Text Key: 155206783
• Report Number: MW5089211
• Device Sequence Number: 1
• Product Code: LYG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/17/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 89-IOS AT 21
• Device Lot Number: CFR 8905350
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 43 YR
• Patient Weight: 70