BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SALTER CANNULA

    MDR report key: 20713178 · Received November 18, 2024

    Report

    Report Number
    3000219639-2024-00132
    Event Type
    Injury
    Date Received
    November 18, 2024
    Date of Event
    June 17, 2024
    Report Date
    October 21, 2024
    Manufacturer
    SALTER LABS
    Product Code
    CCK
    UDI-DI
    00607411302411
    PMA / PMN Number
    K151421
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    (APPROPRIATE HEALTH IMPACT EFFECT/CODE NOT AVAILABLE):PERSISTENT PROBLEM WITH WALKING/GAIT. THE SAMPLE IS REPORTED TO BE AVAILABLE BUT HAS NOT YET BEEN RECEIVED BY THE MANUFACTURER. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. ALL INFORMATION REASONABLY KNOWN AS OF 18 NOV 2024 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY SUN MED HOLDINGS LLC. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO SUN MED HOLDINGS LLC. SUN MED HOLDINGS LLC. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE SUN MED HOLDINGS COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN SUN MED HOLDINGS LLC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED, THE ELDERLY PATIENT'S FEET CAUGHT ON THE TUBING AND SHE FELL ON HER LEFT SIDE AND SUSTAINED AN INJURY TO THE EYEBROW, A BRUISED HIP AND CHEST. SHE CURRENTLY CANNOT WALK AND HAS PAIN ON HER RIGHT SIDE INCLUDING NOT BEING ABLE TO CARRY OR PULL A WALKING SYSTEM ON A TROLLEY. IT IS ADDITIONALLY REPORTED, NOTHING VISIBLE [WAS SEEN] ON THE PELVIC SCAN (AT THE MOMENT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1987661 SALTER CANNULA CANNULA, ADULT, DIVIDED W/7 O2 LINE & 2 CO2 LINE W/FEMALE LUER-LOCK CONNECTOR CCK SALTER LABS SO-1188 UNKNOWN 00607411302411

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Female