ASP GLOBAL
Received Dec 20, 2025 · Event occurred Apr 30, 2025
Report 3004824601-2025-00224 · MDR key 23858576
Device
Generic name
Infant Heel Warmer
Manufacturer
Jiangsu Intco Medical Products Co., LtdModel number
INFHW-ASPLot number
K0629EN
Product problems
- Burst Container or Vessel
- Burst Container or Vessel
Patient
NA · Unknown
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
Narrative
Additional Manufacturer Narrative
THIS FOLLOWUP REPORT IS TO UPDATE THE FACTORY NAME AND ADDRESS TO REFLECT THE EXACT MANUFACTURER LOCATION.
Additional Manufacturer Narrative
THESE MEDICAL DEVICE REPORTS (MDRS) ARE BEING FILED PAST THE REGULATORY REPORTING TIMEFRAME AS THEY ARE A RESULT OF A RETROSPECTIVE REVIEW OF OUR COMPLAINTS. THE MSDS FILE OF INFHW-ASP REVEALED THE PRIMARY COMPOSITION OF INFHW-ASP TO BE SODIUM ACETATE (CAS 127-09-3). SODIUM ACETATE IS NOT REPORTED AS MEETING GHS HAZARD CRITERIA AND IS NOT CLASSIFIED AS A GHS HAZARD. THE MSDS FILE HAZARD SECTION CONFIRMED THAT IT IS NOT HAZARDOUS AS WELL. SODIUM ACETATE IS EQUIVALENT TO SALT AND VINEGAR SOLUTION. THE MEDICAL RECOMMENDATION FOR NEXT COURSE OF ACTION IS TO RINSE THE EXPOSED AREA WITH WATER AND REGARDLESS, EXPOSURE TO INTACT SKIN IS HIGHLY UNLIKELY TO CAUSE LONG-TERM INJURY. NO SERIOUS INJURY WAS REPORTED
Description of Event or Problem
ON (B)(6) 2025, CUSTOMER REPORTED THAT THERE WERE TWO INSTANCES OF INFHW-ASP HEEL WARMER, INFANT EXPLODING ON PATIENT'S HANDS.