MalfunctionIME
MEDLINE
Received May 17, 2026 · Event occurred Apr 17, 2026
Report 1417592-2026-01436 · MDR key 25196720
Device
Generic name
Pack,cold,vinyl,blue,standard,11x14
Manufacturer
Medline Industries, LpCatalog number
MDSPC10
Lot number
VN25264
Product problems
- Material Integrity Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE COLD PACK HAS BURST AT THE SEAM.
Additional Manufacturer Narrative
IT WAS REPORTED THAT THE COLD PACK HAS BURST AT THE SEAM. 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.