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

Model Number US PAT D735,818

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2021

Event Type  malfunction  

Event Description

This fasciablaster device spontaneously fractured into many pieces with sharp shards of plastic.I primarily used it in the shower.It was not in use when it fractured apart.This is the second fasciablaster i've had that did this.The first time i requested a replacement from the company.This time i am reaching out to you.Fda safety report id # (b)(4).

• Brand Name: FASCIABLASTER
• Type of Device: MASSAGER, THERAPEUTIC, MANUAL
• Manufacturer (Section D): ASHLEY BLACK/ ADB INTERESTS, LLC
• MDR Report Key: 11412507
• MDR Text Key: 235030124
• Report Number: MW5099775
• Device Sequence Number: 2
• Product Code: LYG
• Combination Product (y/n): Y
• 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: 03/01/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: US PAT D735,818
• Device Catalogue Number: N/A
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 54 YR
• Patient Weight: 79