MAUDE Adverse Event Report: ADB INTERESTS LLC FASCIABLASTER

Device Problem Insufficient Information (3190)

Patient Problem Cellulitis (1768)

Event Date 06/28/2017

Event Type  Injury  

Event Description

Using faceblaster and fasciablaster release of too many toxins and received cellulitis in my face and was hospitalized for 10 days with intravenous antibiotics.

• Brand Name: FASCIABLASTER
• Type of Device: FASCIABLASTER
• Manufacturer (Section D): ADB INTERESTS LLC
• MDR Report Key: 7832349
• MDR Text Key: 118933986
• Report Number: MW5079498
• Device Sequence Number: 1
• Product Code: IOD
• 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: 08/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/29/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 35 YR
• Patient Weight: 68