BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STERICARE STERILE 0.9% SALINE SOLUTION - 1000ML

    MDR report key: 18300730 · Received December 8, 2023

    Report

    Report Number
    MW5149040
    Event Type
    Injury
    Date Received
    December 8, 2023
    Date of Event
    May 23, 2023
    Report Date
    November 7, 2023
    Manufacturer
    NURSE ASSIST, LLC
    Product Code
    FRO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I USED THE NURSE ASSIST LLC STERILE SALINE PRODUCT TO IRRIGATE A SEROMA IN MY ABDOMEN FROM (B)(6) OF 2023. I HAVE SINCE HAD 3 DÉBRIDEMENT SURGERIES TO CLEAR DAMAGED TISSUE FROM MY WOUND. I HAD TWO AS AN OUT PATIENT AND THE MOST RECENT INPATIENT. THEY ONLY DID A CULTURE ON THE MOST RECENT AND IT GREW OUT MRSA (METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS). I HAVE BEEN PROGRESSIVELY SICKER SINCE MAY. SIGNIFICANT PHYSICAL DETERIORATION SINCE (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1844649 STERICARE STERILE 0.9% SALINE SOLUTION - 1000ML DRESSING, WOUND, DRUG FRO NURSE ASSIST, LLC 6281 23034968

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Hospitalization| L| R| S