BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NURSE ASSIST, LLC

    MDR report key: 19532493 · Received June 13, 2024

    Report

    Report Number
    3002695476-2024-00029
    Event Type
    Injury
    Date Received
    June 13, 2024
    Date of Event
    May 20, 2024
    Report Date
    June 11, 2024
    Manufacturer
    NURSE ASSIST, LLC
    Product Code
    FRO
    PMA / PMN Number
    K083042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A FOLLOW-UP EMAIL WAS SENT TO (B)(6) BY THE COMPLAINT DEPARTMENT ON (B)(6) 2024 REQUESTING ADDITIONAL INFORMATION TO AID WITH REPORTING AND WITH THE INVESTIGATION.

    Description of Event or Problem · 0

    ON (B)(6) 2024, NURSE ASSIST RECEIVED A COMPLAINT VIA VOICEMAIL FROM A HOSPITAL ABOUT A PATIENT NAMED (B)(6) . DESCRIPTION OF VOICEMAIL ON MONDAY, ON (B)(6) 2024: REALLY I'M CALLING IN REGARDS TO A LETTER THAT WE RECEIVED ITS REGARDING OUR PRODUCTS BEING AND STERILIZED AND WE ACTUALLY APPLE TV ACTUALLY HAD AN ISSUE WITH YOU GUYS ACTUALLY IF IT WAS A PRICE WE GOT THIS LETTER BECAUSE IT'S KIND OF MATCHING US UP AT THE SAME TIME THAT WE'RE GOING TO ADDRESS WITH THE PEOPLE THAT WE ALREADY CONTACTED. IF YOU PLEASE GIVE US A CALL BACK PATIENT'S NAME IS (B)(6) HIS PHONE NUMBER IS (B)(6) WE NEED TO SEE WHAT ACTIONS WE NEED TO BE TAKING BECAUSE RIGHT NOW WE HAVE OTHER ACTIONS THAT WERE IN THE PROCESS OF A STARTING AND YEAH THERE IS IT SOMETHING THAT HE'S GONE TO MEDICALLY THAT WE HAVE ACTUALLY POSSIBLY EVEN TO YOU GUYS SO THIS LETTER IS ACTUALLY GOOD TIMING THAT WE RECEIVED IT SO PLEASE GIVE ME A CALL BACK WE GREATLY APPRECIATE THAT I THANK YOU SO MUCH. YEAH I'M SORRY THE EMAIL ADDRESS IS ALSO (B)(6) (B)(6) I THANK YOU SO MUCH SWEETHEART THIS 14 FOR YOU BYE . MANUAL TRANSCRIPT OF VOICEMAIL ON (B)(6) 2024: HI SWEETIE, I'M CALLING IN REGARDS TO A LETTER THAT WE RECEIVED AS ONE YOUR PRODUCTS BEING NOT STERILIZED. WE ACTUALLY HAD A ISSUE WITH YOU GUYS AND WE'RE SURPRISE THAT WE GOT THIS LETTER BECAUSE IT KINDA MATCHES WITH THE SAME TIME WITH WHAT WE'RE GOING THROUGH WITH THE PEOPLE THAT WE ALREADY CONTACTED. CAN YOU PLEASE GIVE US A CALL BACK? THE PATIENT'S NAME IS (B)(6) , (B)(6) . WE'RE WAITING TO SEE WHAT ACTION WE NEED TO BE TAKING BECAUSE NOW WE HAVE OTHER OPTIONS THAT WE'RE IN THE PROCESS OF STARTING. YEAH THIS IS SOMETHING THAT HE'S GONE THROUGH MEDICALLY THAT COULD POSSIBLY BE LINKED TO YOU GUYS. SO THIS LETTER WAS AN ACTUAL GOOD TIMING THAT WE RECEIVED IT. SO GIVE HIM A CALL BACK, WE GREATLY APPRECIATE THAT! THANK YOU SO MUCH. I'M SORRY, THE EMAIL ADDRESS IS ALSO (B)(6) . THANK YOU SO MUCH SWEETHEART. LOOK FORWARD TO HEARING BACK FROM YOU. BYE .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    864467 NURSE ASSIST, LLC 0.9% NORMAL SALINE FOR IRRIGATION USP IN SCREW BOTTLE TOP FRO NURSE ASSIST, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other