MAUDE Adverse Event Report: BTL INDUSTRIES LIMITED VANQUISH

Device Problem Overheating of Device (1437)

Patient Problem Full thickness (Third Degree) Burn (2696)

Event Date 02/17/2014

Event Type  Injury  

Event Description

Reported that a female patient treated by vanquish complained of burns and blisters in the treated area.No signs of injury immediately after the treatment.The following day injury appeared.Patient was seen by md and was instructed on wound management and to cover wound with aquaphor and neosporin.

Manufacturer Narrative

Btl industries followed up with the physician's office to gather additional information.Per the physician's office, patient reported few hot spots during the treatment.User responded by moving applicator away and/or decreasing energy.At the end of the treatment some moisture was felt on the patient's skin.Patient had no complaints of pain or itching in the area.Patient saw a burn specialist and was prescribed antibiotic cream and antibiotic wrap.Specialist said that the patient has 1 second degree burn and 1 third degree burn, making this a reportable event.Based on physician's office information, burns are healing.Per the physician's office, the procedure on (b)(6) 2014 was conducted successfully with no malfunction.Btl industries reviewed the system logs for the treatment date and confirmed that no system malfunction occurred.

• Brand Name: VANQUISH
• Manufacturer (Section D): BTL INDUSTRIES LIMITED; 30 peshtersko shouse blvd; plovdiv 4002 ; BU 4002
• Manufacturer (Section G): BTL INDUSTRIES LIMITED; 30 peshtersko shouse blvd; plovdiv 4002 ; BU 4002
• Manufacturer Contact: 47 loring dr; framingham, MA 01702 ; 8662851656
• MDR Report Key: 3716154
• MDR Text Key: 4332844
• Report Number: 3005028741-2014-00002
• Device Sequence Number: 1
• Product Code: IMJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120093
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Physician
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 03/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 32 YR
• Patient Weight: 99