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

Lot Number 272206494

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/27/2017

Event Type  malfunction  

Event Description

Patient was disconnecting their cooler pack at home post-total knee arthroplasty and noted the electrical (male) connector broke off of the electrical cord into the female receptacle of the cooler itself rendering it all unusable.No harm to patient and they brought the complete cooler back to the hospital for a replacement.

• Brand Name: POLAR CARE CUBE
• Type of Device: PACK, HOT OR COLD, WATER CIRCULATING
• Manufacturer (Section D): BREG, INC.; 2885 loker ave e; carlsbad CA 92010
• MDR Report Key: 7024342
• MDR Text Key: 91830683
• Report Number: 7024342
• 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: 11/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: 272206494
• Other Device ID Number: 10701 AND L94
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/07/2017
• Event Location: Home
• Date Report to Manufacturer: 11/07/2017
• 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
• Patient Age: 69 YR
• Patient Weight: 78