NEOTECH PRODUCTS

Additional Manufacturer Narrative

THE DEVICE WAS NOT RETURNED; THEREFORE, NO EVALUATION COULD BE CONDUCTED ON THE ACTUAL UNIT. RETAINED SAMPLES FROM THE CURRENT INVENTORY OF ALL THREE CATALOG NUMBERS AND THEIR RESPECTIVE DEVICE HISTORY RECORDS (DHRS), WERE REVIEWED, AND NO ISSUES WERE IDENTIFIED. AS THE MANUFACTURER, WE HAVE TAKEN EXTENSIVE STEPS TO MITIGATE THE RISK OF SUCH INCIDENTS. THIS SPECIFIC RISK IS CLEARLY OUTLINED IN OUR DIRECTIONS FOR USE, WHERE WE EMPHASIZE THE NECESSITY OF DIRECT SUPERVISION BY TRAINED HEALTHCARE PROFESSIONALS. THE CAUTION IS ALSO CLEARLY PRINTED ON THE BACK OF THE DEVICE LINER. FURTHERMORE, WE HAVE SPECIFICALLY ADVISED THAT ANY PLACEMENT, REMOVAL, OR REPLACEMENT OF THE DEVICE MUST BE DOCUMENTED IN THE PATIENT'S MEDICAL RECORDS, WHICH IS ESSENTIAL FOR TRACEABILITY AND PATIENT SAFETY. PROPER USE AND DOCUMENTATION BY THE END USER ARE CRITICAL. HAD THE OUTLINED PROCEDURES BEEN FOLLOWED, NOT ONLY WOULD THE PRODUCT DETAILS (E.G., PART AND LOT NUMBERS) HAVE BEEN READILY ACCESSIBLE, BUT IT IS LIKELY THAT THE INCIDENT COULD HAVE BEEN PREVENTED ALTOGETHER. WE KINDLY ASK AND REEMPHASIZE TO OUR CUSTOMERS AND END USERS THE IMPORTANCE OF CAREFULLY REVIEWING AND ADHERING TO ALL PROVIDED INSTRUCTIONS, PARTICULARLY THE CAUTIONS AND WARNINGS. DOING SO ENSURES THE HIGHEST STANDARD OF SAFETY FOR PATIENTS AND SUPPORTS EFFECTIVE INCIDENT MANAGEMENT SHOULD ANY ISSUES ARISE. THIS INCIDENT HAS BEEN LOGGED AND WILL BE MONITORED FOR TRENDING PURPOSES.

Description of Event or Problem

INFANT INGESTED ONE OF THESE ITEMS.