FASCIABLASTER

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-25 for FASCIABLASTER manufactured by Ashley Black/adb Interests, Llc.

Event Text Entries

[87518048] Date is approximate. After using a device called the fascia blaster for several months. I began to experience intense and immobilizing period cramps. I have used the tool, as instructed, on my abdomen. Once i realized the potential connection, i stopped using it. I went to the doctor and may need surgery due to a prolapse. While a prolapsed uterus is very common in women who have had children, the sudden onset as well as the severity of the symptoms made me connect it to my use of this device. I was planning to get surgery, as instructed, but, without intervention, it seems to be improving which is not the usual course. I had horrific bruising from the device and was told that was "good" and supposed to happen. I significantly damaged my body in other ways as well. When i described what happened to me in an open forum, quite a few people came forward with similar stories some of who had not connected it to the use of fasciablaster. This is a horribly dangerous product and needs to be investigated.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5072418
• MDR Report Key: 6893796
• Date Received: 2017-09-25
• Date of Report: 2017-09-24
• Date of Event: 2017-07-15
• Date Added to Maude: 2017-09-26
• 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 Details

• Brand Name: FASCIABLASTER
• Generic Name: COMPONENTS, EXERCISE
• Product Code: IOD
• Date Received: 2017-09-25
• 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

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2017-09-25