MalfunctionIME
MEDLINE
Received Jun 17, 2026 · Event occurred Mar 25, 2026
Report 1417592-2026-00536 · MDR key 25537041
Device
Product problems
- Burst Container or Vessel
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED THAT "1 COUNT HOT AND COLD COMPRESS BUST AT THE SEAMS, AND GEL LIKE OUT". THERE WERE NO REPORTS OF DEATH, SERIOUS INJURY, MEDICAL INTERVENTION, OR FOLLOW UP CARE. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR AGAIN. IN AN ABUNDANCE OF CAUTION, THIS IS A REPORTABLE EVENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS REPORT WILL BE REOPENED AND REEVALUATED.
Description of Event or Problem
CUSTOMER STATED "1 COUNT HOT AND COLD COMPRESS BUST AT THE SEAMS, AND GEL LIKE OUT".