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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DJO, LLC DONJOY; DONJOY ICEMAN CLEARCUBE
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DJO, LLC DONJOY; DONJOY ICEMAN CLEARCUBE Back to Search Results
Model Number 11-0493
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Information (3190)
Event Date 03/14/2018
Event Type  Injury  
Event 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".
 
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Brand Name
DONJOY
Type of Device
DONJOY ICEMAN CLEARCUBE
Manufacturer (Section D)
DJO, LLC
1430 decision street
vista CA 92081 9663
Manufacturer (Section G)
DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V.
carretera libre tijuana tecate
20230 submetropoli el florido
tijuana, 22244
MX   22244
Manufacturer Contact
william fisher
1430 decision street
vista, CA 92081-9663
7607343126
MDR Report Key7366743
MDR Text Key103338545
Report Number9616086-2018-00006
Device Sequence Number1
Product Code ILO
UDI-Device Identifier00190446257189
UDI-Public00190446257189
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Patient
Type of Report Initial
Report Date 03/23/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/23/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Model Number11-0493
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
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