MAUDE Adverse Event Report: DJO, LLC CHATTANOOGA ULTRASOUND APPLICATOR, 5 CM, GRAY; ULTRASONIC DIATHERMY FOR USE IN APPLYING THERAPEUTIC DEEP HEAT

Model Number	27383
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	11/15/2019
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 "during patient visit e-stim machine used on patient.When patient went home she noticed 4 distinct burn marks on her back where the e-stim pads had been placed.Patient went to urgent care where she was dx with partial thickness burns and silvadene dressing placed along with order to follow up with her pcp (primary care physician) and wound care clinic.".

• Brand Name: CHATTANOOGA ULTRASOUND APPLICATOR, 5 CM, GRAY
• Common Device Name: ULTRASONIC DIATHERMY FOR USE IN APPLYING THERAPEUTIC DEEP HEAT
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista CA 92081
• MDR Report Key: 9670740
• Report Number: 3012446970-2020-00003
• Device Sequence Number: 11455141
• Product Code: IMI
• UDI-Device Identifier: 00888912021906
• UDI-Public: 00888912021906
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K031116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/04/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: 27383
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2020
• Initial Report FDA Received Date: 02/05/2020
• 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