BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INCA

    MDR report key: 235130 · Received August 10, 1999

    Report

    Report Number
    2243662-1999-00001
    Event Type
    Injury
    Date Received
    August 10, 1999
    Date of Event
    September 9, 1997
    Report Date
    August 10, 1999
    Manufacturer
    ACKRAD LABORATORIES, INC.
    Product Code
    BYE
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    NEONATAL PT ON ACKRAD INCA MED DEVICE; AN ASSEMBLY FOR MAINTAINING CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP). THE DEVICE IS ALLEGED TO HAVE CAUSED A NASAL SEPTAL ABRASION LEADING TO PERMANENT INJURY OF THE NASAL SEPTUM. ACKRAD DID NOT BECOME AWARE OF THE EVENT UNTIL NOTIFIED OF A PENDING LAWSUIT ON JULY 14, 1999.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INCA NASAL CPAP BYE ACKRAD LABORATORIES, INC. UNK 5816

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO Disability