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

Model Number	INFANT CUREWRAP
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The infant curewrap involved in the incident was discarded at the hospital and was therefore not available for investigation.No photos or the location of the leak were provided.Without the ability to investigate the wrap, a root cause of the reported leak cannot be established.A review of past complaints indicates that prior to this incident there has only been one other complaint related to this lot number.The wrap involved in the previous incident was discarded at the hospital and the leak could therefore not be confirmed, however samples of 2 infant curewraps from production were tested on a criticool system for approximately 24 hours and no leaks were observed.The manufacturing and leak testing history records for this lot number were reviewed and no deviations or anomalies were identified.All curewraps are 100% leak tested by the manufacturer prior to release for shipment.No patient injury was reported.Belmont will continue to monitor and trend similar reports of this nature and take further action if required.Should additional information become available, a supplemental report will be provided.
Event or Problem Description
Belmont medical technologies received a report from the user facility that an infant curewrap leaked while in use causing the baby to become wet.The curewrap was replaced and therapy continued without further issue.

• Brand Name: CRITICOOL
• Common Device Name: THERMAL REGULATING SYSTEM
• Manufacturer (Section D): BELMONT MEDICAL TECHNOLOGIES; 780 boston road; billerica MA 01821
• MDR Report Key: 11136122
• Report Number: 1219702-2021-00005
• Device Sequence Number: 845860
• Product Code: DWJ
• UDI-Device Identifier: 07290012127199
• UDI-Public: 07290012127199
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K083662
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: INFANT CUREWRAP
• Device Catalogue Number: 500-03521
• Device Lot Number: M192461
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/09/2020
• Initial Report FDA Received Date: 01/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1