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 Code	Unspecified Eye / Vision Problem (4471)
Date of Event	01/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Phlebotomist is activating the heel warmer to use to warm patient hand.When she was squeezing it, it burst and exploded to her right eye.Phlebotomist sent to er for treatment.No after effects noted per their email.
Additional Manufacturer Narrative
A user facility complaint was received on 1/20/2023, reporting, "phlebotomist is activating the heel warmer to use to warm patient hand.When she was squeezing it, it burst and exploded to her right eye.Phlebotomist sent to er for treatment." the sample is not available for return to deroyal for evaluation.This investigation is not complete at this time.No further information is available at this time.We will provide follow-up report once more information is concluded from the investigation.
Additional Manufacturer Narrative
The sample is not available for return to deroyal for evaluation as it had been discarded.Deroyal industries inspected (b)(4) cases of hnicu-100 from the same lot as the complaint product and found no issues.Instructions for use, production records, and failure modes and effects analysis (fmea) were reviewed and no discrepancies or gaps were found.From february 2022 to present, deroyal has sold (b)(4) eaches of hnicu-100 with a total of (b)(4) complaints in that time frame.This is equates to a ratio of (b)(4).Root cause: was determined to be unknown by deroyal industries as the investigation could not find any evidence of the reported problem.Potential root cause determined by deroyal: while the true root cause could not be determined, the potential root cause could be, but is not limited to, a material defect or an end user error.While there were no specific corrective or preventative actions taken, deroyal will continue to monitor for trends around this issue.This 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 newman ; 200 debusk lane; powell, TN 37849 ; 8653622106
• MDR Report Key: 19928696
• Report Number: 2320762-2023-00001
• Device Sequence Number: 2725468
• Product Code: MPO
• UDI-Device Identifier: 00749756312929
• UDI-Public: 00749756312929
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2023

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
• Device Model Number: HNICU-100
• Device Lot Number: 58079495
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/20/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/07/2024
• Supplement Report FDA Received Date: 08/07/2024
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown