MAUDE Adverse Event Report: DJO, LLC DONJOY; DONJOY ICEMAN CLEARCUBE

Model Number	11-0493
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Information (3190)
Date of Event	03/14/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Complaint received that alleges "he put device on a tv tray when going to bed and condensation caused it to slide and pull his shoulder.Hung up before completing information.When i called back he stated he wouldn't say anything else, and that we speak to his attorney and he would sue the company".

• Brand Name: DONJOY
• Common Device Name: DONJOY ICEMAN CLEARCUBE
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista CA 92081 9663
• MDR Report Key: 7366743
• Report Number: 9616086-2018-00006
• Device Sequence Number: 1976893
• Product Code: ILO
• UDI-Device Identifier: 00190446257189
• UDI-Public: 00190446257189
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 03/23/2018

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: No Information
• Device Model Number: 11-0493
• 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: 03/23/2018
• 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