MAUDE Adverse Event Report: BREG, INC. BREG PC CUBE; PACK, HOT OR COLD, WATER CIRCULATING

Model Number	PC CUBE W/ M/U XL WO
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/16/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The tubing to the patient end of the device leaked all over the patient's dressing and bed.Manufacturer response for pack, hot or cold, water circulating, breg (per site reporter): none yet.

• Brand Name: BREG PC CUBE
• Common Device Name: PACK, HOT OR COLD, WATER CIRCULATING
• Manufacturer (Section D): BREG, INC.; 2885 loker ave east; carlsbad CA 92010
• MDR Report Key: 7295664
• Report Number: 7295664
• Device Sequence Number: 1368177
• Product Code: ILO
• UDI-Device Identifier: 00672736017739
• UDI-Public: (01)00672736017739
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/23/2018
• Report Date (Section F): 02/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: PC CUBE W/ M/U XL WO
• Device Catalogue Number: 10710
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 02/23/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NO; NO OTHER THERAPIES
• Date Report Sent to FDA: 02/23/2018