inforMED
MalfunctionMPO

ASP GLOBAL

Received Feb 11, 2026 · Event occurred Feb 5, 2026

Report 3004824601-2026-00018 · MDR key 24315402

Device

Generic name

Infant Heel Warmer

Model number

INFHW-ASP

Lot number

J0610EN

Product problems

  • Burst Container or Vessel

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

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

IT WAS REPORTED TO ASP ON 05FEB2026, CUSTOMER HAD TWO EVENTS OF ASP HEEL WARMERS EXPLODING OUT OF THE PACKAGE UPON ACTIVATION. DATE EVENT OCCURED WAS 17DEC2025, NO INJURIES WERE REPORTED.