ASP GLOBAL

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 WE RECEIVED A CUSTOMER COMPLAINT THAT ONE OF OUR HEEL WARMERS WAS LEAKING AND DRIPPED ONTO A PATIENT'S PANTS. NO ADVERSE EVENTS WERE REPORTED.