MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. HYDRO-TEMP COVER W/O FM 1 1/8"; WARMER, INFANT RADIANT

Model Number	HNICU-03
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Hyperthermia (1909)
Date of Event	01/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A user facility reported, "the probe covers not properly molding and adhering to the patient's skin to hold down the nicu probe to the patient's skin.Several patients have overheated due to the probe not properly molding and adhering to the patient's skin." deroyal industries, inc.Requested return of the device, but it has not yet been received.This investigation is not complete at this time.No further information is available at this time.We will provide follow up report when additional information becomes available.
Event or Problem Description
A user facility reported, "the probe covers not properly molding and adhering to the patient's skin to hold down the nicu probe to the patient's skin.Several patients have overheated due to the probe not properly molding and adhering to the patient's skin.".

• Brand Name: HYDRO-TEMP COVER W/O FM 1 1/8"
• Common Device Name: WARMER, INFANT RADIANT
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 185 richardson way; maynardville TN 37807
• Manufacturer (Section G): DEROYAL INDUSTRIES, INC.; 185 richardson way; maynardville TN 37807
• Manufacturer Contact: reagan facemire ; 200 debusk lane; powell, TN 37849 ; 8653622106
• MDR Report Key: 24222173
• Report Number: 1034876-2026-00001
• Device Sequence Number: 8196967
• Product Code: FMT
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: K191425
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: HNICU-03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/30/2026
• Supplement Report FDA Received Date: 08/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown