NEOTECH PRODUCTS

Additional Manufacturer Narrative

THE DEVICE WAS NOT RETURNED; THEREFORE, NO EVALUATION COULD BE CONDUCTED ON THE ACTUAL UNIT. RETAINED SAMPLES FROM SAME LOT NUMBER AND THE CURRENT LOT NUMBER WERE RE-INSPECTED, AND NO ABNORMALITIES WERE IDENTIFIED. IN ADDITION, THE DEVICE HISTORY RECORDS (DHR) OF THE MENTIONED INVENTORY WERE REVIEWED, AND NO NONCONFORMITIES WERE FOUND. BASED ON THE CLINICAL INFORMATION PROVIDED AND OUR INTERNAL TESTING, WE WERE UNABLE TO DETERMINE A DEFINITIVE CAUSE FOR THE REPORTED INCIDENT. HOWEVER, POSSIBLE CONTRIBUTING FACTORS THAT COULD NOT BE RULED OUT INCLUDE INADEQUATE SIZING OF THE USED DEVICE (STRAPS CAN BE TRIMMED FOR PROPER FIT, AND ALSO A SMALLER SIZE OF DEVICE IS AVAILABLE), AND INSUFFICIENT SUPERVISING OF THE PATIENT. AS PER DFU STATEMENT: NEOSHADES SHOULD ONLY BE USED WHILE THE PATIENT IS UNDER THE CONTINUOUS, DIRECT SUPERVISION OF HEALTHCARE PROFESSIONALS. A REVIEW OF OUR COMPLAINT HISTORY REVEALED NO TRENDS, AND BASED ON COMPLAINT RATIO CALCULATIONS, THE INCIDENT APPEARS TO BE RARE. WHILE WE STAND BY THE INTEGRITY OF OUR PRODUCT AND THE THOROUGHNESS OF OUR INSTRUCTIONS, PROPER USE AND DOCUMENTATION BY THE END USER ARE CRITICAL. HAD THE OUTLINED PROCEDURES BEEN FOLLOWED, 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 COMPLAINT WILL CONTINUE TO BE MONITORED FOR TRENDING PURPOSES AND HAS BEEN LOGGED IN THE APPROPRIATE RECORDS AND CHARTS.

Description of Event or Problem

LAST NURSING CHECK-UP AT 8:30 A.M. INSTALLATION OF THE PHOTOTHERAPY GLASSES WAS CHECKED, GLASSES WERE IN PLACE. THE BABY STARTED TO FUSS AT 9:45 A.M. (SEEN THROUGH A SCOPE) WHILE I WAS CARING FOR ANOTHER CHILD IN ISOLATION. AT 10:00 A.M., THE DOCTOR NOTICED THAT THE PHOTOTHERAPY GLASSES WERE NO LONGER ON THE BABY'S EYES EVEN THOUGH THE PHOTOTHERAPY WAS IN PROGRESS. THE BABY HAD BEEN WITHOUT EYE PROTECTION FOR BETWEEN 15 AND 90 MINUTES DURING PHOTOTHERAPY. CONSEQUENCES: OPHTHALMOLOGICAL EXAMINATION PERFORMED, BURNING NOTED IN THE RIGHT EYE, TREATMENT WITH EYE OINTMENT (RETINOL). THE DEVICE WAS ALSO MOVED ON ANOTHER PATIENT, BUT IT WAS PLACED BACK AGAIN, AND THERE WERE NO CONSEQUENCES.