GEL-E DONUT - MEDIUM

Description of Event or Problem

CHILDREN'S MEDICAL VENTURES (CHMV) RECEIVED A REPORT DETAILING A PRODUCT ISSUE ASSOCIATED WITH THE GEL-E DONUT PRODUCT LINE. THE COMPLAINT ALLEGATION STATED THAT MOLD AND MOISTURE WAS FOUND IN SOME OF THE PACKAGES CONTAINING EXPIRATION DATES OF 12/07/2014-02/02/2015. NO RESULTING EFFECT ON A PATIENT OR END USER HAS BEEN REPORTED, THE PRODUCT WAS NOT PLACED INTO PATIENT USE.

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. CHMV HAS DETERMINED THAT DUE TO AN INCREASED AMOUNT OF CUSTOMER COMPLAINTS ASSOCIATED WITH THE REPORTED ISSUE, A FORMAL INVESTIGATION HAS BEEN INITIATED. ONCE THE INVESTIGATION HAS BEEN CONCLUDED, A FOLLOW-UP ADDITIONAL INFORMATION REPORT WILL BE FILED DETAILING THE FINDINGS. ADDITIONAL EXP. DATE - 02/02/2014, ADDITIONAL DEVICE MANUFACTURE DATE - 05/12/2013.