BEUDAMED
    FDA Adverse Event Other Summary report: N

    SALTER STYLE 1600 SERIES CANNULA

    MDR report key: 2440852 · Received February 1, 2012

    Report

    Report Number
    2921601-2012-00002
    Event Type
    Other
    Date Received
    February 1, 2012
    Date of Event
    January 9, 2012
    Report Date
    February 1, 2012
    Manufacturer
    SALTER LABS
    Product Code
    CAT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    ON (B)(4) 2012, (B)(6) CONTACTED SALTER LABS REGARDING HER HUSBAND WHO HAD TO SEEK MEDICAL ATTENTION ON (B)(6) 2012 WHILE USING SALTER'S 1600 PRODUCT. THE PT STATED THE CANNULA SMELLED "LIKE PAINT" AND BURNED HIS NASAL PASSAGES. A SALTER REPRESENTATIVE SPOKE TO THE PT TO FIND OUT HIS STATUS AND THE STATUS OF THE PRODUCT AND THE PT SAID THAT HE FELT THE SMELL ORIGINATED FROM AN ENVELOPE THE PRODUCT IS PROVIDED TO HIM IN (ENVELOPE IS PROVIDED BY THE (B)(6) COMPANY), BUT THAT THE SMELL REMAINED WITH THE PRODUCT EVEN AFTER BEING REMOVED FROM THE ENVELOPE. THE PT SAID THAT HE DISPOSED OF THAT PARTICULAR CANNULA AND WENT TO HIS DOCTOR REGARDING THE BURNING SENSATION. THE DOCTOR PRESCRIBED HIM MEDICATION (PT DID NOT STATE THE TYPE OF MEDICATION) AND THE PT STATED THE SYMPTOMS HAVE SUBSIDED AND HE IS ABLE TO TOLERATE THE CANNULA NOW. SINCE THE PT DISPOSED OF THE CANNULA, THE PRODUCT REFERENCED ABOVE WILL NOT BE RETURNED. ADDITIONALLY, NO LOT NUMBER INFO WAS PROVIDED; THEREFORE, WE WILL NOT BE ABLE TO INSPECT SIMILAR PRODUCTS FROM THE SAME LOT OR REVIEW THE DEVICE HISTORY RECORD. THIS IS AN INITIAL AND FINAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SALTER STYLE 1600 SERIES CANNULA NASAL CAT SALTER LABS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other