MAUDE Adverse Event Report: BTL INDUSTRIES LIMITED VANQUISH; SHORTWAVE DIATHERMY

Device Problems Unexpected Therapeutic Results (1631); Device Operates Differently Than Expected (2913)

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

Event Date 07/17/2015

Event Type  Injury  

Manufacturer Narrative

Btl industries followed up with the physician´s office to gather additional information.Based on information received no errors or device malfunction occurred during the treatment.The system logs were reviewed for the treatment date and confirmed that no system malfunction occurred during the treatment.Burns are listed in the operator´s manual as a potential adverse effect.The patient is treated by the wound care specialist.As of (b)(6) 2015 the injury is not getting better.A f/u report will be made to the agency if and when new information is received about this case.

Event Description

It was reported that a female patient treated by vanquish to lower back complained of burn in the treated area.Patient is treated for wound with burn cooling patches, bacitracin and ibuprofen.Patient was seen by urgent care hospital.She was diagnosed with 3rd degree burn.Patient was referred to wound care specialist.

• Brand Name: VANQUISH
• Type of Device: SHORTWAVE DIATHERMY
• 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: jan zarsky ; 47 loring dr; framingham, MA 01702 ; 8662851656
• MDR Report Key: 5010695
• MDR Text Key: 23300756
• Report Number: 3005028741-2015-00003
• 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
• Report Date: 08/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/18/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2012
• 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: 60 YR
• Patient Weight: 140