MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. JETSTREAM COLD THERAPY KIT

Model Number T700

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Information (3190)

Event Date 08/07/2018

Event Type  malfunction  

Event Description

The device is leaking at the connecting hose.Several of these kits have been returned for the same reason.The patient had to return to the hospital for a new kit.

• Brand Name: JETSTREAM COLD THERAPY KIT
• Type of Device: COLD THERAPY KIT
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 200 debusk ln.; powell TN 37849
• MDR Report Key: 7884785
• MDR Text Key: 120551325
• Report Number: 7884785
• Device Sequence Number: 1
• Product Code: ILO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: T700
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/28/2018
• Event Location: Home
• Date Report to Manufacturer: 09/18/2018
• Type of Device Usage: N
• Patient Sequence Number: 1