MAUDE Adverse Event Report: DJO, LLC DONJOY; PACK, HOT OR COLD, WATER CIRCULATING

Model Number	11-0679-9-00000
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/04/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Patient found to have a wet ace wrap from the cold therapy pad.Unsure where the pad was leaking water.Pad removed, ace wrap reapplied.Dressing underneath ace wrap was dry and intact.

• Brand Name: DONJOY
• Common Device Name: PACK, HOT OR COLD, WATER CIRCULATING
• Manufacturer (Section D): DJO, LLC; 1430 decision st; vista CA 92081
• MDR Report Key: 9218292
• Report Number: 9218292
• Device Sequence Number: 2733813
• Product Code: ILO
• UDI-Device Identifier: 00888912003629
• UDI-Public: (01)00888912003629
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 10/07/2019
• Report Date (Section F): 10/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 11-0679-9-00000
• Device Lot Number: 141908
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/22/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 10/07/2019