BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NURSE ASSIST, LLC

    MDR report key: 19826520 · Received July 25, 2024

    Report

    Report Number
    3002695476-2024-00043
    Event Type
    Injury
    Date Received
    July 25, 2024
    Report Date
    July 2, 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

    AN EMAIL WAS SENT TO PRODUCT REMOVE INFO EMAIL ADDRESS BY (B)(6) ON 11/08/23. THE EMAIL WAS FORWARDED TO THE COMPLAINTS DEPARTMENT ON 6/24/24, 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 6/25/24 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 PURCHASED THIS PRODUCT AND USED IT FOR WOUND MANAGEMENT AFTER I HAD MY BREASTS REMOVED FOR CANCER. I GOT AN INFECTION TWICE THAT REQUIRED SURGERY. THE INFECTION LASTED SEVERAL WEEKS. IT COMPROMISED MY HEALING AND CAUSED ME TO BE OFF WORK AND GO TO A HYPERBARIC CHAMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365349 NURSE ASSIST, LLC Dressing, wound, drug FRO NURSE ASSIST, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R