BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NATUS BILIBAND EYE PROTECTOR

    MDR report key: 5961761 · Received September 19, 2016

    Report

    Report Number
    3018859-2016-00015
    Event Type
    Injury
    Date Received
    September 19, 2016
    Report Date
    August 23, 2016
    Manufacturer
    NATUS MEDICAL INCORPORATED
    Product Code
    FOK
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER STATED THAT THEY HAVE NOT RECORDED LOT NUMBER OF THE PRODUCT INVOLVED. CUSTOMER STATED THEY HAVE SAMPLES AT THE HOSPITAL AND WILL BE ABLE TO SEND THEM FOR INVESTIGATION, BUT IT IS UNKNOWN IF THE SAMPLES ARE FROM THE SAME LOT INVOLVED IN THE INCIDENT REPORTED. NATUS MEDICAL CURRENTLY WAITING FOR PRODUCT TO BE RETURNED. WHEN PRODUCT IS RETURNED AND EVALUATED, A FOLLOW-UP REPORT WILL BE SUBMITTED. PENDING PRODUCT RETURN.

    Additional Manufacturer Narrative · 1

    IN ADDITION TO REPORTS OF CONTACT DERMATITIS, A STRONG ACIDIC CHEMICAL SMELL WAS REPORTED WHEN OPENING THE BOX OF BILIBAND PRODUCTS. THE CUSTOMER WAS ABLE TO PROVIDE NATUS PRODUCTS FROM THE SAME LOT IN QUESTION FOR INVESTIGATION. A NON-SCIENTIFIC APPROACH OF SMELLING THE CLEAR PLASTIC PACKAGES UPON OPENING WAS USED TO CHECK IF A SIMILAR ODOR COULD BE DETECTED. NO SUCH SMELL WAS NOTED. IT IS POSSIBLE THAT THE ODOR HAD BEEN SLOWLY RELEASED THROUGH THE NON-AIRTIGHT PACKAGE DURING SHIPPING AND STORAGE. PRODUCTION DOCUMENTS WERE REQUESTED AND SUBSEQUENTLY PROVIDED BY THE SUPPLIER. THE FOLLOWING DOCUMENTATION WAS PROVIDED: BILL OF MATERIALS FOR BILIBAND, BIOCOMPATABILITY REPORT, PLAIN FILM SGS REPORT, PROCESS FLOW OF MANUFACTURING BILIBAND AND VECLOR MATERIAL SAFETY DATA SHEET. A REVIEW OF THE LISTED DOCUMENTATION DID NOT REVEAL ANY SUSPICIOUS SOURCE OF AN ODOR, AND THIS INVESTIGATION HAS BEEN DETERMINED TO BE INCONCLUSIVE. A SEARCH OF SIMILAR COMPLAINTS RESULTED IN ONE SIMILAR COMPLAINT. IN THIS CASE, THE CUSTOMER WAS UNRESPONSIVE AND THE DEVICE WAS NOT RETURNED FOR EVALUATION. ANY REPORT OF SIMILAR COMPLAINTS WILL BE INVESTIGATED BY NATUS IMMEDIATELY. PLEASE NOTE THAT ADDITIONAL INFORMATION, SUCH AS PATIENT INFORMATION, WAS REQUESTED FROM THE CUSTOMER WITH NO RESPONSE.

    Description of Event or Problem · 1

    THIS REPORT IS FOR INCIDENT #1. CUSTOMER REPORTED THAT THEY ARE AWARE OF 5 INCIDENTS OF PATIENTS EXPERIENCING SKIN RASH. THE RASH WAS PRESENT ON THE ENTIRE AREA THAT WOULD COME INTO CONTACT WITH THE BLUE FOAM PORTION ON THE PERIORBITAL AREA OF THE INFANTS. THERE WAS NO RASH UNDER THE WHITE ELASTIC SECURING PORTION. THE SKIN BECAME REDDENED. THERE WERE NO BLISTERS, OPEN LESIONS, OR DRAINAGE FROM THE SKIN. SMALL RAISED BUMPS WERE NOTED ON THE SKIN WHERE IT WAS REDDENED. IN TWO OF THE SITUATIONS, PHOTOTHERAPY TREATMENT HAD TO BE STOPPED EARLY AS THE RASH WAS SO SEVERE. THERE WERE NO OTHER INTERVENTIONS OR TREATMENTS DONE AS A RESULT. NO OTHER ABNORMALITIES WERE NOTED. CUSTOMER IS UNSURE OF THE PART NUMBER OF BILIBANDS, BUT BELIEVES THAT #900642 AND #900643 WERE INVOLVED. CUSTOMER WAS NOT ABLE TO PROVIDE NATUS WITH LOT NUMBERS FOR THE PRODUCT INVOLVED IN THESE INCIDENTS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY ARE AWARE OF 5 INCIDENTS OF PATIENTS EXPERIENCING SKIN RASH. THE RASH WAS PRESENT ON THE ENTIRE AREA THAT WOULD COME INTO CONTACT WITH THE BLUE FOAM PORTION ON THE PERIORBITAL AREA OF THE INFANTS. THERE WAS NO RASH UNDER THE WHITE ELASTIC SECURING PORTION. THE SKIN BECAME REDDENED. THERE WERE NO BLISTERS, OPEN LESIONS, OR DRAINAGE FROM THE SKIN. SMALL RAISED BUMPS WERE NOTED ON THE SKIN WHERE IT WAS REDDENED. IN TWO OF THE SITUATIONS, PHOTOTHERAPY TREATMENT HAD TO BE STOPPED EARLY AS THE RASH WAS SO SEVERE. THERE WERE NO OTHER INTERVENTIONS OR TREATMENTS DONE AS A RESULT. NO OTHER ABNORMALITIES WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612099 NATUS BILIBAND EYE PROTECTOR BILIBAND FOK NATUS MEDICAL INCORPORATED 900642 , 900643

    Patients

    Seq Age Sex Outcome Treatment
    1 Other