FASCIABLASTER

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-02 for FASCIABLASTER manufactured by Ashley Black / Adb Interests Llc.

Event Text Entries

[81956629] I had been using (b)(6) fasciablasters (the big blaster, the mini2 and faceblaster) on my body to reduce cellulite. I have hemosiderin staining of the back of my legs. My cellulite on my legs is much worse now.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5071367
• MDR Report Key: 6766896
• Date Received: 2017-08-02
• Date of Report: 2017-08-02
• Date of Event: 2017-06-12
• Date Added to Maude: 2017-08-04
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Sequence Number: 1

• Brand Name: FASCIABLASTER
• Generic Name: FASCIABLASTER
• Product Code: IOD
• Date Received: 2017-08-02
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ASHLEY BLACK / ADB INTERESTS LLC

Device Sequence Number: 2

• Brand Name: MINI 2
• Generic Name: MINI 2
• Product Code: IOD
• Date Received: 2017-08-02
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: ASHLEY BLACK / ADB INTERESTS LLC

Device Sequence Number: 3

• Brand Name: FACEBLASTER
• Generic Name: FACEBLASTER
• Product Code: IOD
• Date Received: 2017-08-02
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 3
• Device Event Key: 0
• Manufacturer: ASHLEY BLACK / ADB INTERESTS LLC

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2017-08-02