INFANT HEEL WARMER

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.

Description of Event or Problem

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.