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

Device Problem Insufficient Information (3190)

Patient Problems Partial thickness (Second Degree) Burn (2694); Full thickness (Third Degree) Burn (2696)

Event Date 05/26/2015

Event Type  Injury  

Manufacturer Narrative

Btl followed up with the health care facility to gather additional information.Per the health care facility patient tolerated the treatment well.Burns are listed in the operator´s manual as a potential adverse effect.The patient's injury is healing well.The system logs were reviewed for the treatment dates and confirmed that no system malfunction occurred during the treatment dates.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 abdomen experienced second degree and third degree burns in the treated area.Patient underwent a surgical intervention.

• 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: 5104081
• MDR Text Key: 26758453
• Report Number: 3005028741-2015-00004
• Device Sequence Number: 1
• Product Code: IMJ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K120093
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Report Date: 09/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2015
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/28/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2014
• 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: 53 YR
• Patient Weight: 94