GEL-E DONUT - EXTRA SMALL

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. THE GEL PRODUCTS INSTRUCTIONS FOR USE STATE THAT BEFORE USE, REMOVE THE OUTER PLASTIC BAG AND WIPE ALL SURFACES WITH AN ANTIBACTERIAL AGENT. THE INSTRUCTIONS FOR USE FURTHER STATE TO COVER WITH A DISPOSABLE COVER OR SOFT CLOTH BEFORE PATIENT USE. 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 INFORMATION REPORT WILL BE FILED DETAILING THE FINDINGS.

Description of Event or Problem

CHILDREN'S MEDICAL VENTURES (CHMV) RECEIVED (B)(4) FROM THE FDA ON (B)(4) 2014, INFORMING THE BUSINESS OF A MEDWATCH REPORT DETAILING A PRODUCT ISSUE ASSOCIATED WITH THE EXTRA-SMALL GEL-E DONUT POSITIONING DEVICES. THE COMPLAINT ALLEGATION STATES THAT A CUSTOMER FOUND A MOLD LIKE SUBSTANCE ON THE SURFACE AND INSIDE THE GEL. TWO OF THE AFFECTED PRODUCT WERE REPORTEDLY OPENED IN THE PATIENT'S ROOM BEFORE NOTICING THE ISSUE. AN ADDITIONAL THREE AFFECTED PRODUCTS WERE ALSO REPORTEDLY FOUND IN STORAGE. THERE IS NO ALLEGATION OF ANY AFFECTED PRODUCTS BEING PUT INTO PATIENT USE AND NO ALLEGATION OF PATIENT HARM HAS BEEN REPORTED. THE COMPLAINT ISSUE ALLEGED BY THE CUSTOMER WAS NOT ABLE TO BE CONFIRMED BECAUSE THE PRODUCT HAS NOT BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. THE CUSTOMER REPORTED THE EXPIRATION DATE OF THE PRODUCT AS BEING 07/29/2014.