GEL-E DONUT - SMALL

Description of Event or Problem

CHILDREN'S MEDICAL VENTURES (CHMV) RECEIVED A REPORT OF A PRODUCT ISSUE ASSOCIATED WITH THE SMALL GEL-E DONUT POSITIONING DEVICES. THE COMPLAINT ALLEGATION REPORTS AN ISSUE OF MOLD ASSOCIATED WITH FIVE CASES OF THE PRODUCT. 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. NO UNIQUE PRODUCT IDENTIFIERS SUCH AS LOT NUMBERS OR EXPIRATION DATES HAVE BEEN REPORTED.

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.