GEL-E DONUT - MEDIUM

Description of Event or Problem

CHILDREN'S MEDICAL VENTURES (CHMV) REC'D A REPORT DETAILING A PRODUCT ISSUE ASSOCIATED WITH THE GEL-E DONUT PRODUCT LINE. THE COMPLAINT ALLEGATION STATED THAT THE MOLDY PRODUCT WAS USED ON A BURN PATIENT WHO NOW HAS MOLD IN THE BURN AREA. NO RESULTING EFFECT OF THE EXPOSURE TO THE PATIENT HAD BEEN REPORTED. A F/U CONVERSATION WITH THE REPORTER OF THE EVENT, THE ATTENDING PHYSICIAN, LATER REVEALED THAT THE REPORTED INCIDENT TOOK PLACE IN A BURN UNIT. THE DOCTOR STATED THAT THERE IS ALREADY A REASONABLE INSTANCE ASSOCIATED WITH FUNGAL GROWTH AND BURN VICTIMS. THE PATIENT WAS ALREADY BEING TREATED WITH ANTI-FUNGAL MEDICATION DUE TO THE INHERENT RISK OF FUNGAL INFECTION ALREADY ASSOCIATED WITH BURN VICTIM PATIENTS. THE DOCTOR STATED THAT THE PATIENT DID NOT SHOW SIGNS OF INFECTION IN CULTURE TESTS PRIOR TO EXPOSURE. HOWEVER, SUBSEQUENT TESTING SHOWED SIGNS OF INFECTION. THE IDENTIFIED INFECTION RESULTED IN THE MEDICATION THE PATIENT WAS BEING TREATED WITH TO BE SWITCHED TO ONE THAT IS KNOWN TO BETTER COMBAT THAT SPECIFIC INFECTION. THE DOCTOR STATED THAT HE CANNOT SAY THAT THE PATIENT'S INFECTION WAS DIRECTLY RELATED TO THE EXPOSURE OF GEL-E DONUT MOLD BUT THAT IT WAS A POSSIBLE CONTRIBUTING FACTOR. THE DOCTOR STATED THAT HE DID NOT FEEL THE EVENT MET THE DEFINITION OF HARM. THE PATIENT WAS REPORTEDLY A MALE TODDLER. HOWEVER, THE EXACT AGE OF THE PATIENT NOT KNOWN. THERE IS NO REPORTED LASTING IMPACT ON THE PATIENT. THE INFECTION WAS TREATED WITH ANTI-FUNGAL MEDICATION AND THE PATIENT IS DOING FINE. NONE OF THE AFFECTED PRODUCT HAS BEEN RETURNED FOR EVALUATION. NO UNIQUE PRODUCT IDENTIFIERS HAVE BEEN PROVIDED SUCH AS LOT NUMBERS OR PRODUCT EXPIRATION DATES.

Additional Manufacturer Narrative

(B)(4). THE GEL PRODUCTS ARE INTENDED TO PROVIDE SUPPORT FOR INFANTS IN A HOSPITAL ENVIRONMENT AND A CAREGIVER IS TO BE PRESENT DURING USE. NORMAL USE WILL CONFORM TO ACCEPTED MEDICAL PRACTICE AND TO THE LABELING INSTRUCTIONS. A FORMAL INVESTIGATION HAS BEEN INITIATED BY CHMV TO INVESTIGATE THE IDENTIFIED PRODUCT ISSUE. ONCE THE INVESTIGATION HAS BEEN CONCLUDED, A F/U ADD'L INFO REPORT WILL BE FILES DETAILING THE FINDINGS.