MAUDE Adverse Event Report: BELMONT MEDICAL TECHNOLOGIES CRITICOOL; THERMAL REGULATING SYSTEMS

Catalog Number 200-00236

Device Problem No Apparent Adverse Event (3189)

Patient Problem Skin Irritation (2076)

Event Date 10/04/2018

Event Type  malfunction  

Manufacturer Narrative

Subcutaneous fat necrosis occurs in 5% of infants undergoing cooling treatment.We have reached out to the hospital to obtain further information regarding this event.Should additional information become available, a supplemental report will be submitted accordingly.

Event Description

The belmont sales representative received an email from a physician at the user facility, who reported that a (b)(6) old infant developed subcutaneous fat necrosis at the base of the neck, on the left side of the neck, and at the left posterior thigh, and now has elevated serum calcium.

• Brand Name: CRITICOOL
• Type of Device: THERMAL REGULATING SYSTEMS
• Manufacturer (Section D): BELMONT MEDICAL TECHNOLOGIES; 780 boston road; billerica MA 01821
• Manufacturer (Section G): BELMONT MEDICAL TECHNOLOGIES; 780 boston road; billerica MA 01821
• Manufacturer Contact: sabrina belladue ; 780 boston road; billerica, MA 01821 ; 9783307637
• MDR Report Key: 8035494
• MDR Text Key: 126078874
• Report Number: 1219702-2018-00040
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 200-00236
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1