ASP GLOBAL
Received Mar 9, 2026 · Event occurred Aug 25, 2023
Report 3004824601-2026-00020 · MDR key 24553136
Device
Product problems
- Burst Container or Vessel
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
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. NO LOT NUMBER WAS PROVIDED FOR THIS COMPLAINT, THEREFORE THE DHR COULD NOT BE REVIEWED. NO SAMPLES WERE SENT BACK FOR EVALUATION. COMPLAINT FILE HISTORY WAS REVIEWED AND IT WAS CONFIRMED THAT NO OTHER COMPLAINTS HAVE BEEN REPORTED ON THIS ITEM FOR LEAKING/RUPTURING. WE WILL CONTINUE TO MONITOR COMPLAINTS FOR ANY TRENDS.
Description of Event or Problem
ON AUGUST 25, 2025 WE RECEIVED A CUSTOMER COMPLAINT THAT ICA01 PACK COLD, INSTANT, 6X9 HAS A SEAL THAT RUPTURED AND THE CONTENTS SPILLED OUT. NO ADVERSE EVENTS WERE REPORTED.