MAUDE Adverse Event Report: BREG, INC. BREG POLAR CARE GLACIER

Model Number 10901

Device Problem Insufficient Information (3190)

Patient Problems Erythema (1840); Swelling (2091); Impaired Healing (2378)

Event Date 02/09/2015

Event Type  No Answer Provided  

Manufacturer Narrative

No product was returned for evaluation.Breg has reviewed internal complaint files and finds no record of this incident previously being reported.This is the first notification received for this incident.Device has not been returned.

Event Description

Breg received notification through fdas medwatch program of a patient who allegedly experienced unexpected redness, swelling, and delayed wound healing following total knee arthoplasty and the application of cold therapy.The medwatch report references the polar care glacier as the cold therapy device.

• Brand Name: BREG POLAR CARE GLACIER
• Type of Device: POLAR CARE GLACIER
• Manufacturer (Section D): BREG, INC.; 2885 loker avenue east; carlsbad, ca CA 92010
• Manufacturer (Section G): BREG, INC.; 2885 loker avenue east; carlsbad CA 92010
• Manufacturer Contact: carol emerson ; 2885 loker avenue east; carlsbad, CA 92010 ; 7607955823
• MDR Report Key: 5066107
• MDR Text Key: 25337072
• Report Number: 2028253-2015-00006
• 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: Manufacturer
• Source Type: other
• Reporter Occupation: Health Professional
• Report Date: 09/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 10901
• Device Catalogue Number: 10901
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/12/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 75 YR