inforMED
MalfunctionMPO

MEDLINE

Received May 27, 2026 · Event occurred Apr 26, 2026

Report 1417592-2026-01764 · MDR key 25311049

Device

Generic name

Warmer,heel,infant,mtl Disc,cloth Strap

Catalog number

MDS138009

Product problems

  • No Apparent Adverse Event

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

IT WAS REPORTED THAT "ONE OF OUR INFANT HEEL WARMERS RUPTURED AND SPILLED ITS LIQUID CONTENTS". 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 "ONE OF OUR INFANT HEEL WARMERS RUPTURED AND SPILLED ITS LIQUID CONTENTS".