BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NURSE ASSIST, LLC

    MDR report key: 19614886 · Received June 26, 2024

    Report

    Report Number
    3002695476-2024-00032
    Event Type
    Injury
    Date Received
    June 26, 2024
    Date of Event
    December 11, 2023
    Report Date
    June 17, 2024
    Manufacturer
    NURSE ASSIST, LLC
    Product Code
    FRO
    PMA / PMN Number
    K083042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN EMAIL WAS SENT TO THE PRODUCT REMOVAL INFO EMAIL ADDRESS BY (B)(6) ON 12/12/2023. THE EMAIL WAS FORWARDED TO THE COMPLAINTS DEPARTMENT ON 5/24/24, WHICH INITIATED NURSE ASSIST'S INVESTIGATION OF THE REPORTED INCIDENT AND DETERMINATION THAT THE NOTED INCIDENT WAS REPORTABLE. A FOLLOW-UP EMAIL WAS SENT TO (B)(6) BY THE COMPLAINTS DEPARTMENT ON 5/23/24 AND 6/10/2024 REQUESTING ADDITIONAL INFORMATION TO AID WITH REPORTING AND WITH THE INVESTIGATION. THE PRODUCT REMOVAL INFO EMAIL ADDRESS WAS INTENDED TO BE USED SOLELY FOR FACILITATING RETURN AND REPLACEMENT OF PRODUCT AND WAS NOT BEING REVIEWED FOR COMPLAINT INFORMATION, WHICH RESULTED IN THE DELAY OF REPORTING THIS INCIDENT. THE PRODUCT REMOVAL INFO EMAIL INBOX IS BEING EXPEDITIOUSLY REVIEWED TO IDENTIFY ANY OTHER INCIDENT RELATED INFORMATION THAT WOULD BE CONSIDERED AS A COMPLAINT.

    Description of Event or Problem · 0

    COMMENTS INCLUDED IN EMAIL RECEIVED FROM COMPLAINTS: I AM WRITING TO EXPRESS MY CONCERN ABOUT YOUR PRODUCT. I RECEIVED A RECALL NOTICE IN NOVEMBER, BUT THE PRODUCT THAT WAS RECALLED HAD ALREADY BEEN USED DUE TO THE FACT IT HAD BEEN PURCHASED MONTH PRIOR. AT FIRSTI DIDN'T THINK MUCH OF IT BECAUSE TO MY KNOWLEDGE WE (MY OFFICE) HAD NOT HAD ANY ISSUES OF BAD OUTCOMES. HOWEVER, YESTERDAY I HAD A SECOND PATIENT CONTACT ME THAT HAD ISSUES WITH THE TRANSPLANT WE PERFORMED ON HIM. THE OUTCOME WAS POOR GROWTH AND FOLLICULITIS. WE USE THE 0.9% NS TO HYDRATE THE FOLLICULAR UNITS AS WELL AS WASH THE SCALP DURING THE PROCEDURE. SO NOW I AM LOOKING AT 2 PATIENTS WITH BAD OUTCOMES. IS THERE A REMEDY FOR THIS? THE TRANSPLANTS WILL RESULT IN A LOSS OF (B)(6) (TWELVE THOUSAND) DOLLARS ON MY END.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    550345 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