BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NATUS BILIBAND

    MDR report key: 2267858 · Received September 7, 2011

    Report

    Report Number
    3018859-2011-00005
    Event Type
    Malfunction
    Date Received
    September 7, 2011
    Date of Event
    August 11, 2011
    Report Date
    September 7, 2011
    Manufacturer
    OLYMPIC MEDICAL INCORPORATED
    Product Code
    FOK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE DEVICE THAT WAS THE SUBJECT OF THIS COMPLAINT WAS NOT AVAILABLE FOR EVAL, NATUS MEDICAL EVALUATED PRODUCT FROM THE SAME LOT ((B)(4)) AS WELL AS PRODUCT FROM A LOT BUILT BEFORE ((B)(4)) AND A LOT BUILT AFTER ((B)(4)) AFTER THE SUSPECT LOT. IN ALL CASES, THE LABELS WERE ADHERED TO THE BILIBANDS. PULL TESTS WERE PERFORMED ON THESE LABELS. NONE OF THE LABELS TESTED WERE REMOVED WITHOUT A REASONABLE AMOUNT OF FORCE. (B)(4) HAS DISTRIBUTED BILIBANDS FOR EIGHT YEARS. SINCE THIS IS THE FIRST REPORT OF AN INFANT REMOVING THE LABEL DURING USE AND SINCE THE ISSUE COULD NOT BE DUPLICATED WITH TESTING, (B)(4) BELIEVES THIS IS AN ISOLATED INCIDENT. OTHER THAN SUBMITTING THIS MDR, NO FURTHER ACTION IS ADVOCATED AT THIS TIME.

    Description of Event or Problem · 1

    INFANT BEING TREATED WITH PHOTOTHERAPY SOMEHOW REMOVED THE LABEL FROM THE NATUS BILIBAND EYE PROTECTOR; THE LABEL WAS FOUND BY NICU PERSONNEL IN THE INFANT'S HAND. NO INJURY OCCURRED. HOWEVER, THERE WAS THE POTENTIAL OF A CHOKING HAZARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NATUS BILIBAND NEONATAL EYE PAD FOK OLYMPIC MEDICAL INCORPORATED REGULAR SIZE F11101210R

    Patients

    Seq Age Sex Outcome Treatment
    1