BEUDAMED
    FDA Adverse Event Other Summary report: N

    SALTER LABS OXYGEN TUBING

    MDR report key: 2464150 · Received February 17, 2012

    Report

    Report Number
    2921601-2012-00003
    Event Type
    Other
    Date Received
    February 17, 2012
    Date of Event
    January 29, 2012
    Report Date
    February 16, 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

    A PT AND HER CAREGIVER CALLED SALTER LABS TO REPORT AN EVENT THAT HAPPENED THE PREVIOUS DAY. THE PT TRIPPED OVER TUBING AND SUSTAINED MINOR INJURIES (BRUISED ELBOWS AND A SMALL SCRAPE/LACERATION ON HER WRIST). THE PT DID NOT SEEK MEDICAL ATTENTION; HOWEVER RECURRENCE OF A SIMILAR EVENT COULD POTENTIALLY RESULT IN A SERIOUS EVENT REQUIRING MEDICAL ATTENTION. TO DATE, THE TUBING HAS NOT BEEN RETURNED, ALTHOUGH IT HAS BEEN REQUESTED TWICE. THEREFORE, IT IS THOUGHT THAT FAILURE ANALYSIS WON'T BE ABLE TO BE PERFORMED. SHOULD THE PRODUCT BE RETURNED, A F/U REPORT WILL BE SUBMITTED. THIS IS A FINAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SALTER LABS OXYGEN TUBING 50' OXYGEN TUBING CAT SALTER LABS 2050 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other