BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NURSE ASSIST, LLC

    MDR report key: 18402502 · Received December 27, 2023

    Report

    Report Number
    3002695476-2023-00037
    Event Type
    Injury
    Date Received
    December 27, 2023
    Date of Event
    November 15, 2023
    Report Date
    December 22, 2023
    Manufacturer
    NURSE ASSIST, LLC
    Product Code
    FRO
    PMA / PMN Number
    K083042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ON 08-DEC-23, NURSE ASSIST RECEIVED A COMPLAINT VIA E-MAIL FROM (B)(6) OF THE FOLLOWING EVENT. DESCRIPTION FROM E-MAIL:THIS AFTERNOON I CONTACTED NURSE ASSIST WITH A QUERY AND SPOKE WITH CHERYL WHO RECOMMENDED THAT I REACH OUT TO THIS EMAIL ADDRESS TO THE COMPLAINT DEPARTMENT. I WAS A PATIENT AT THE GREEN MOUNTAIN SURGICAL CENTER IN VT ON (B)(6) 2023 WHERE I HAD A DOUBLE MASTECTOMY WITH RECONSTRUCTION WHERE I 2 DAYS AFTER THE SURGERY I DEVELOPED AN INFECTION IN MY LEFT BREAST SKIN AND SOFT TISSUES. THE IMPLANT WAS SUBSEQUENTLY REMOVED ON (B)(6) 2023. I LEARNED THAT I HAD BEEN CONTAMINATED WITH A MULTI DRUG RESISTANT BACTERIA: PSEUDOMONAS AERUGINOSA. I LEARNED THAT IT WAS VERY LIKELY THAT THE RECALLED SALINE SOLUTION WAS USED ON ME DURING THE (B)(6) SURGERY. I WAS TOLD THE BRAND NAME USED WAS MCKESSON. I WOULD LIKE TO BE INFORMED OF HOW MCKESSON (THE DISTRIBUTOR) AND THE GREEN MOUNTAIN SURGICAL CENTER (THE CONSUMER?) WAS ALERTED AND NOTIFIED OF THE SALINE SOLUTION RECALL THAT WAS ISSUED BY NURSE ASSIST LLC AND THE FDA ON 11/6/2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2265384 NURSE ASSIST, LLC Dressing, wound, drug FRO NURSE ASSIST, LLC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention