MAUDE Adverse Event Report: DJO GLOBAL COMPANY DONJOY ICEMAN; PACK, HOT OR COLD, WATER CIRCULATING

Lot Number 100915-01M

Device Problem Leak/Splash (1354)

Patient Problem No Information (3190)

Event Date 12/18/2015

Event Type  malfunction  

Event Description

The device was attached to patient, when it started leaking at the point where the rubber tubing inserts into the control mechanism.The device was removed from service.

• Brand Name: DONJOY ICEMAN
• Type of Device: PACK, HOT OR COLD, WATER CIRCULATING
• Manufacturer (Section D): DJO GLOBAL COMPANY; 1430 decision street; vista CA 92081
• MDR Report Key: 5398370
• MDR Text Key: 37085575
• Report Number: 5398370
• Device Sequence Number: 1
• Product Code: ILO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: 100915-01M
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/21/2015
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 12/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1