BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CENTRAL LINE

    MDR report key: 13178728 · Received January 5, 2022

    Report

    Report Number
    MW5106510
    Event Type
    Injury
    Date Received
    January 5, 2022
    Date of Event
    January 2, 2022
    Report Date
    January 2, 2022
    Manufacturer
    UNK
    Product Code
    FOZ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SPONTANEOUS. SPOKE TO PHARMACIST AT HOSPITAL AND PROVIDED REMODULIN DOSING INFORMATION. PATIENT HAS BEEN ADMITTED DUE TO MALFUNCTION OF CENTRAL LINE. NO OTHER INFORMATION KNOWN. PRESCRIBER HAS BEEN NOTIFIED. PRESCRIBER REMS ID: (B)(6), PATIENT REMS ID: (B)(6). REPORTED TO (B)(6) BY HEALTH PROFESSIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    792115 CENTRAL LINE CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female Hospitalization REMODULIN