MAUDE Adverse Event Report: DJO, LLC CHATTANOOGA VECTRA GENISYS 4CH STIM PKG, US STD W/CART; STIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT

Model Number	2798
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Scarring (2061); Full thickness (Third Degree) Burn (2696)
Date of Event	05/14/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No device was returned for evaluation.If the device is received, a follow-up report will be submitted upon completion of product evaluation.
Event or Problem Description
It was reported that the device failed during treatment, thereby causing the patient to sustain third-degree burns and irreparable scarring of the damaged tissue.Patient has reportedly required ongoing treatment, care, and surgery thereby adversely causing injuries to the patient's health, strength and activity, having sustained, inter alia, injuries to her body and other injuries.No further details are available at this time.

• Brand Name: CHATTANOOGA VECTRA GENISYS 4CH STIM PKG, US STD W/CART
• Common Device Name: STIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista CA 92081 9663
• MDR Report Key: 8917026
• Report Number: 9616086-2019-00058
• Device Sequence Number: 11215518
• Product Code: IMG
• UDI-Device Identifier: 00888912294768
• UDI-Public: 00888912294768
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K031077
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 2798
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2019
• Initial Report FDA Received Date: 08/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Disability