MAUDE Adverse Event Report: DJO LLC AIRCAST; CRYO/CUFF IC W/KNEE, LG

Catalog Number	51A11B
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Pain (1994); Electric Shock (2554)
Date of Event	03/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the patient that the unit is giving electric shocks and pain that lasted up to two weeks.
Additional Manufacturer Narrative
It was reported by the patient that the unit is giving electric shocks and pain that lasted up to two weeks.The patient tried unplugging the unit and plugging it back in, the device was being used on the patients' knee since (b)(6) 2025.The patient fills the unit to the minimum line the ice cubes.The device has not been returned for evaluation.The root cause could not be established.If additional information regarding this reported event becomes available a supplemental report to this document will be submitted.

• Brand Name: AIRCAST
• Common Device Name: CRYO/CUFF IC W/KNEE, LG
• Manufacturer (Section D): DJO LLC; 5919 sea otter place; ste 200; carlsbad CA 92010
• Manufacturer (Section G): DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V.; carretera lobre tijuana tecate; 20230 parque industrial el flo; tijuana, b.c. 22245, mex 22245 ; MX 22245
• Manufacturer Contact: jim pomeroy ; 5919 sea otter place; ste 200; carlsbad, CA 92010
• MDR Report Key: 21748994
• Report Number: 9616086-2025-00035
• Device Sequence Number: 13146001
• Product Code: ILO
• UDI-Device Identifier: 00888912009133
• UDI-Public: 00888912009133
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: E201844
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/01/2025

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: 51A11B
• Device Lot Number: 31016
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2025
• Initial Report FDA Received Date: 04/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female