BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NATUS BILIBAND

    MDR report key: 2278982 · Received September 22, 2011

    Report

    Report Number
    3018859-2011-00006
    Event Type
    Malfunction
    Date Received
    September 22, 2011
    Date of Event
    August 19, 2011
    Report Date
    September 22, 2011
    Manufacturer
    NATUS MEDICAL INCORPORATED
    Product Code
    FOK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NATUS MEDICAL INCORPORATED HAS DISTRIBUTED BILIBANDS FOR EIGHT YEARS. NATUS HAS NOT CONSIDERED VELCRO ADHESION COMPLAINTS TO BE REPORTABLE. THIS MDR IS BEING SUBMITTED BECAUSE THE HOSPITAL REPORTING THIS COMPLAINT ALSO SUBMITTED A REPORT TO (B)(4) SAFETY AGENCY. NATUS CAPA(B)(4) IS OPEN TO TRACK PRODUCT IMPROVEMENTS, INCLUDING VELCRO ADHESION, FOR THE NATUS BILIBAND.

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO DISTRIBUTION PARTNER THAT VELCRO GRIP DID NOT HOLD FOR A NATUS BILIBAND DURING TREATMENT. THERE WAS NO PT INJURY. CUSTOMER FILED REPORT WITH SAFETY AGENCY IN (B)(4) ALLEGING THAT LOOSE VELCRO IS A CLINICAL RISK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NATUS BILIBAND NEONATAL EYE PAD FOK NATUS MEDICAL INCORPORATED PREMATURE SIZE F1109107P

    Patients

    Seq Age Sex Outcome Treatment
    1