MAUDE Adverse Event Report: BELMONT MEDICAL TECHNOLOGIES INFANT CUREWRAP® 2.5 - 4KG; CUREWRAP COOLING BLANKET / WRAP

Model Number	500-03518
Medical Device Problem Codes	Fluid/Blood Leak (1250); Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Received baby on therapeutic cooling with curewrap cooling jacket on.The staff observed the jacket was wet on the head area and soaking through the sheets.All other areas of the jacket was dry and the jacket was not filled with water.After the staff noticed this, they replaced the cooling jacket.
Additional Manufacturer Narrative
The internal complaint file (b)(4) has been logged for this incident for traceability.The wrap involved in this incident has not yet returned to belmont for investigation.There is no patient impact as a result of the alleged incident.The leak is visibly obvious to the user.An add water alarm will generate in the event not enough water is in the device to thermoregulate the patient.The wrap can be exchanged to continue thermoregulation.The operator's manual informs the user, "if moisture or leaks are discovered in the connecting hose and/or wrap, turn off the criticool device, disconnect the power cable from its power source, and correct the problem before proceeding." the manual also provides a troubleshooting guide for water leaks, as well as the following warning statement: "water may drip from the inlet tubes of the wraps.Be sure that no electrical device or outlet is located under the criticool's water inlet or wrap tubes.When disconnecting wraps from the criticool confirm that the clamps are tight, to prevent water leaking from the wrap."all curewraps are 100% leak tested by the manufacturer prior to release for shipment.The wrap involved in this incident has not been returned for investigation to this point.Belmont is currently waiting on return of the curewrap.Without results of the device investigation, no final conclusions can be drawn.A follow-up report will be submitted once the investigation is complete and additional information becomes available.
Additional Manufacturer Narrative
The wrap involved in the incident was not available for investigation.Therefore, a thorough investigation into the reported leak could not be carried out.Additional information was provided from the medical device safety officer that a potential cause of the leaks is accidental damage from a needle electrode puncturing the fabric of the wrap.The user confirmed that there was no patient harm as a result of the alleged incident.The root cause of the reported issue could not be determined.The customer was reminded to avoid inserting any sharp objects between the patient and the wrap.The medical device safety officer will perform training with the departments to avoid future occurrences.No further issues have been reported.We will continue to monitor these incidents closely and take further corrective and preventive action if required.

• Brand Name: INFANT CUREWRAP® 2.5 - 4KG
• Common Device Name: CUREWRAP COOLING BLANKET / WRAP
• Manufacturer (Section D): BELMONT MEDICAL TECHNOLOGIES; 780 boston road; billerica
• Manufacturer (Section G): BELMONT MEDICAL TECHNOLOGIES; 780 boston road; billerica MA 01821
• Manufacturer Contact: garet tierney ; 780 boston road; billerica, MA 01821
• MDR Report Key: 24192377
• Report Number: 1219702-2026-00003
• Device Sequence Number: 15447698
• Product Code: DWJ
• UDI-Device Identifier: 17290012127189
• UDI-Public: 17290012127189
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2026

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: 500-03518
• Device Lot Number: M243231
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/27/2026
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown