ASP GLOBAL
Received Dec 19, 2025 · Event occurred Aug 21, 2023
Report 3004824601-2025-00225 · MDR key 23852078
Device
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
Description of Event or Problem
ON 21AUG2023, CUSTOMER REPORTED THAT IWA03 PACK, INSTANT WARM, 6"X6.5" EXPLODED ON A PATIENT AND SOME OF THE CONTENTS GOT IN HER EYE.
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 IWA03 REVEALED THE PRIMARY COMPOSITION OF IAW03 TO BE SODIUM ACETATE (CAS 6131-90-4). 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 FOR EXPOSURE TO THE EYES IS TO RINSE THE EXPOSED AREA THOROUGHLY WITH WATER AND REGARDLESS, EXPOSURE IS HIGHLY UNLIKELY TO CAUSE LONG-TERM INJURY. NO SERIOUS INJURY WAS REPORTED.