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 Burn(s) (1757)

Event Date 02/01/2023

Event Type  Injury  

Event Description

It was reported that the device allegedly caused pain and a burn to the patient during treatment.

Manufacturer Narrative

It was reported that the device allegedly caused pain and a burn to the patient during treatment.The degree of burn was not reported, it was reported the patient was seeing a dermatologist for treatment.Enovis performed an inspection on the actual device returned.The unit passed functional and safety testing.The product met manufacturer specifications.If additional reporting of this event becomes available it will be provided as a supplemental to this report.

• 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; ste 200; carlsbad CA 92010
• Manufacturer (Section G): DJO, LLC; 5919 sea otter place; ste 200; carlsbad CA 92010
• Manufacturer Contact: jim pomeroy ; 5919 sea otter place; ste 200; carlsbad, CA 92010 ; 5128346301
• MDR Report Key: 16449097
• MDR Text Key: 310327500
• Report Number: 9616086-2023-00006
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 2738
• Device Catalogue Number: 2738
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/01/2023
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other