BEUDAMED
    FDA Adverse Event Injury Summary report: N

    16 SOFT-X

    MDR report key: 17516374 · Received August 11, 2023

    Report

    Report Number
    MW5123323
    Event Type
    Injury
    Date Received
    August 11, 2023
    Date of Event
    August 7, 2014
    Report Date
    August 20, 2014
    Manufacturer
    SALTER LABS
    Product Code
    CAT
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    THE NASAL CANNULA DEVICE IS MANUFACTURED BY SALTER LABS MODEL 16SOFT-X (X LENGTH). THIS " DEVICE IS NOT MANUFACTURED BY LNOGEN INC. PATIENT REPORTED FACIAL SWELLING AFTER USE OF 4" SALTER LABS "SOFT CANNULA", INOGEN ITEM NUMBER RP-169, SALTER LAB LOT NUMBER (10) 050514. PATIENT PROVIDED PERMISSION TO CONTACT DOCTOR. (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2192600 16 SOFT-X CANNULA, NASAL, OXYGEN CAT SALTER LABS 50514

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Unknown