inforMED
MalfunctionKYX

SWEET-EASE

Received Mar 30, 2026 · Event occurred Feb 3, 2026

Report 24708599 · MDR key 24708599

Device

Generic name

Sucrose Solution

Model number

99044

Lot number

25275

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

MOLD WAS DISCOVERED FLOATING IN A CONTAINER OF SWEET-EASE. ABOUT 0.1 -0.2ML OF SWEET EASE WAS ADMINISTERED PRIOR TO DISCOVERY. THERE WAS NO OBVIOUS PUNCTURES OR HOLES IN THE PRODUCT BUT UPON CLOSE INSPECTION AFTER DISCOVERY THE FOIL ON TO MAY NOT HAVE BEEN FULLY APPLIED.