MAUDE Adverse Event Report: BTL INDUSTRIES LIMITED VANQUISH

Device Problem Insufficient Information (3190)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 12/31/2013

Event Type  Injury  

Manufacturer Narrative

Btl industries followed up with the physician's office to gather additional information.Per the physician's office patient reported hot spots during the treatment.And also, patient reports that she did try to "tough it out" even when the treatment was getting a little too hot.Per the information provided by physician office, the procedure on (b)(6) 2013 was conducted with no malfunctions.Btl industries reviewed the system logs for the treatment date and confirmed that no system malfunction occurred.A f/u report will be made to the agency if and when new information is received about this case.

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 doctor and was prescribed topical burn cream silvadene and antibiotic doryx - 125 mg.

• Brand Name: VANQUISH
• Manufacturer (Section D): BTL INDUSTRIES LIMITED; 30 peshtersko shous blvd; plovdiv 4002 ; BU 4002
• Manufacturer (Section G): BTL INDUSTRIES LTD; 30 peshtersko shouse blvd; plovdiv 4002 ; BU 4002
• Manufacturer Contact: 47 loring dr; framingham, MA 01702 ; 8662851656
• MDR Report Key: 3641112
• MDR Text Key: 19457808
• Report Number: 3005028741-2014-00001
• 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: 02/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2014
• 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: 01/13/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2013
• 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: 51 YR
• Patient Weight: 54