MAUDE Adverse Event Report: BTL VANQUISH VANQUISH

Device Problem Insufficient Information (3190)

Patient Problems Radiation Burn (1755); Pain (1994); Swelling (2091)

Event Date 09/08/2015

Event Type  Injury  

Event Description

I had 2 treatments with btl vanquish (fat reducing device) in a doctor's office.I have severe radio frequency burns and 3 large hard lumps in my abdominal area.Going to a new doctor for help and relief as i have been in pain for 2 weeks and no relief in sight.The doctor's office that offers the procedure is not sure what has happened, but said it will go away.Two weeks have past and nothing has changed.

• Brand Name: VANQUISH
• Type of Device: VANQUISH
• Manufacturer (Section D): BTL VANQUISH
• MDR Report Key: 5113814
• MDR Text Key: 27203626
• Report Number: MW5056629
• Device Sequence Number: 0
• Product Code: IMJ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Report Date: 09/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2015
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 73