MAUDE Adverse Event Report: DJO, LLC DONJOY; PAD, KNEE, MANUAL COLD

Model Number	11-1316-0-02000
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Information (3190)
Date of Event	01/24/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Complaint received that alleges "following an operation for a total knee replacement, as part of recovery i was given a knee pad filled with icy water to help reduce the swelling, item to be use at home.It sprung a leak but unfortunately the water came out in a jet and landed further away on customer laptop.Laptop destroy and had to buy a new one".

• Brand Name: DONJOY
• Common Device Name: PAD, KNEE, MANUAL COLD
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista CA 92081 9663
• MDR Report Key: 7374838
• Report Number: 9616086-2018-00007
• Device Sequence Number: 13867402
• Product Code: ILO
• UDI-Device Identifier: 00888912016582
• UDI-Public: 00888912016582
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/20/2018

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: Lay User/Patient
• Device Model Number: 11-1316-0-02000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other