MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. INFANT HEEL WARMER; INFANT HEEL WARMER (CHEMICAL HEAT PACK)

Model Number	HNICU-100
Medical Device Problem Code	Explosion (4006)
Health Effect - Clinical Codes	Rash (2033); Local Reaction (2035); Eye Irritation (4803)
Date of Event	12/06/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A user facility reported, "the product "exploded" during use of the product.The provider had an exposure to their eye.".
Additional Manufacturer Narrative
A user facility reported, "the product "exploded" during use of the product.The provider had an exposure to their eye." deroyal industries, inc.Requested return of the device but it not yet been received.The 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.
Additional Manufacturer Narrative
A user facility reported, "the product "exploded" during use of the product.The provider had an exposure to their eye." deroyal industries, inc.Requested return of the device and it was received on 1/19/2026.An inspection of product at the distribution center was reviewed on 357 cases and all were found to be acceptable and within specification.Specifications for manufacturing were reviewed and found to have validated ranges for inner and outer bag lengths.Upon reviewing the returned sample, it was found that the length of inner bag was higher than the validated specification which resulted in the inner bag becoming sealed to the outer bag.A complaint to sales ratio was conducted from (b)(6) 2023 to (b)(6) 2025 and was found to be (b)(4).Root cause: inner bag length specification was not met and caused a defect with the inner bag becoming sealed with the outer bag.Corrective and preventive actions: machine operators were retrained on the operational qualifications and specifications for the product.Deroyal will continue to monitor for trends around this item and issue.The investigation is complete at this time.No further information is available at this time.We will provide follow-up report if additional information becomes available.

• Brand Name: INFANT HEEL WARMER
• Common Device Name: INFANT HEEL WARMER (CHEMICAL HEAT PACK)
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 1595 highway 33 south; new tazewell TN 37825
• Manufacturer (Section G): DEROYAL INDUSTRIES, INC.; 1595 highway 33 south; new tazewell TN 37825
• Manufacturer Contact: reagan facemire ; 200 debusk lane; powell, TN 37849 ; 8653622106
• MDR Report Key: 23815363
• Report Number: 2320762-2025-00020
• Device Sequence Number: 9963637
• Product Code: MPO
• UDI-Device Identifier: 50749756312924
• UDI-Public: 50749756312924
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K954716
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2026

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-100
• Device Lot Number: 62482877
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 01/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown