MAUDE Adverse Event Report: DJO LLC CHATTANOOGA; APPLICATOR 5CM BLUE CALIBR

Catalog Number	27335
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	06/13/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.
Event or Problem Description
It was reported that getting very hot and burned couple of our patients.
Additional Manufacturer Narrative
It was reported that the device was getting very hot and burned a couple of patients.The device was returned and evaluated; error not duplicated.The us applicator works fine, no problems detected.The root cause could not be established.

• Brand Name: CHATTANOOGA
• Common Device Name: APPLICATOR 5CM BLUE CALIBR
• 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
• MDR Report Key: 19736585
• Report Number: 9616086-2024-00053
• Device Sequence Number: 12551647
• Product Code: IMI
• UDI-Device Identifier: 00888912021876
• UDI-Public: 00888912021876
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K031116
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2024

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: Lay User/Patient
• Device Catalogue Number: 27335
• Device Lot Number: T121816
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2024
• Supplement Date Received by Manufacturer: 08/21/2024
• Initial Report FDA Received Date: 07/13/2024
• Supplement Report FDA Received Date: 09/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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