MAUDE Adverse Event Report: DJO LLC INTELECT TRANSPORT COMBO PKG US STD; STIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT

Model Number	2738
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Full thickness (Third Degree) Burn (2696)
Date of Event	06/21/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the device allegedly caused a crackling noise, smoke from an electrode and resulted in a 3rd degree burn to the patient that was being treated.
Additional Manufacturer Narrative
It was reported that the device allegedly caused a crackling noise, smoke from an electrode and resulted in a 3rd degree burn to the patient that was being treated.It was initially reported to enovis that the patient experienced only a brown demarcation with surrounding redness and that the patient stated, "oh, that's nothing, i'm fine".Enovis performed an inspection on the actual device returned.The unit passed functional and safety testing.The product met manufacturer specifications.Possible root causes include moisture or misapplication of the electrodes.(response to mw5111204).

• Brand Name: INTELECT TRANSPORT COMBO PKG US STD
• Common Device Name: STIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT
• Manufacturer (Section D): DJO LLC; 5919 sea otter place; suite 200; carlsbad CA 92010
• Manufacturer (Section G): DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V.; carretera libre tijuana tecate; 20230 parque industrial el flo; tijuana, b.c. 22245 ; MX 22245
• Manufacturer Contact: jim pomeroy ; 5919 sea otter place; carlsbad; vista, CA 92010 ; 5128346301
• MDR Report Key: 15298433
• Report Number: 9616086-2022-00019
• Device Sequence Number: 5839085
• Product Code: IMG
• UDI-Device Identifier: 00888912021883
• UDI-Public: 00888912021883
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K040285
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/25/2022

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: 2738
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2022
• Initial Report FDA Received Date: 08/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown