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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 06/21/2022

Event Type  Injury  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 298652160
• Report Number: 9616086-2022-00019
• Device Sequence Number: 1
• Product Code: IMG
• UDI-Device Identifier: 00888912021883
• UDI-Public: 00888912021883
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040285
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 2738
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2022
• Date Manufacturer Received: 08/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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): Other