MAUDE Adverse Event Report: DJO LLC ANKLE CUFF ONLY; PACK, HOT OR COLD, WATER CIRCULATING

Model Number	10A01
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Temperature Problem (3022)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	10/12/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that, cuffs were applied at the surgery center and patient education was performed at the surgery center as well on instruction for using the devices.The ankle leaked at the toes and other up top of ankle.She later developed frost bite leading to wounds and plastic surgery.The reported issue was originally reported to enovis january 24, 2023 and entered as a quality issue in our complaint system for a leak.After receiving an inquiry from enovis legal department the original email communication from originator was requested.Customer's email on jan 24, 2023, states "she later developed frost bite leading to wounds and plastic surgery.The frost bite had developed by her follow up on (b)(6) 2022".A new complaint was opened to document the injury.The product was returned to enovis on 02/06/2023.Reported quality issue for leaks had been previously investigated so this cuff was not evaluated as was disposed of.In our instructions for use and labels applied to our cryo/cuff coolers include warnings to protect patients from thermal injuries such as this.There is no indication within customers email that these warnings were heeded.If additional information regarding the reported event is submitted at a future date, this investigation will be re-evaluated.
Event or Problem Description
It was reported that, cuffs were applied at the surgery center and patient education was performed at the surgery center as well on instruction for using the devices.The ankle leaked at the toes and other up top of ankle.She later developed frost bite leading to wounds and plastic surgery.

• Brand Name: ANKLE CUFF ONLY
• Common Device Name: PACK, HOT OR COLD, WATER CIRCULATING
• 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 libre tijuana tecate; 20230 parque industrial el flo; tijuana, b.c. 22245 ; MX 22245
• Manufacturer Contact: jim pomeroy ; 5919 sea otter place; ste 200; carlsbad, CA 92010
• MDR Report Key: 19136648
• Report Number: 9616086-2024-00029
• Device Sequence Number: 9438278
• Product Code: ILO
• UDI-Device Identifier: 00888912001342
• UDI-Public: 00888912001342
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/24/2023

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 Model Number: 10A01
• Device Lot Number: TJ00134220525
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2024
• Initial Report FDA Received Date: 04/18/2024
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Female