BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRESSING ++ CHANGE TRY CTRLLN

    MDR report key: 11848120 · Received May 18, 2021

    Report

    Report Number
    MW5101422
    Event Type
    Injury
    Date Received
    May 18, 2021
    Report Date
    May 13, 2021
    Manufacturer
    UNK
    Product Code
    OXQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PER SPONTANEOUS CALL FROM PATIENT "PATIENT STATED THAT SHE HAS AN ALLERGY (SYMPTOM DETAILS UNKNOWN) TO THE DRESSING CHANGE TRAY CENTRAL LINE AND REQUESTED TO REMOVE THAT RX SO THAT WE DONT SEND IT OUT NEXT TIME. SAID THAT SHE IS ALSO HAVING ISSUES WITH THE CASSETTES SINCE THE LAST COUPLE OF TIMES (DATES NOT REPORTED) THAT THEY ARE LEAKING BUT PT HAS EXTRAS OF THOSE SO PT SAID IF IT CONTINUES HAPPENING THEN SHE WILL CALL BACK TO DISCUSS WITH RPH AND SAID THAT SHE DIDN'T WANT TO SPEAK TO RPH AT THE MOMENT ABOUT IT". UNKNOWN IF FAULTY SUPPLIES ARE AVAILABLE FOR INVESTIGATION, LOTS AND EXPIRATION DATES WERE NOT REPORTED. NO ADDITIONAL INFORMATION OR DATES REPORTED. REPORTED TO (B)(6) BY: PATIENT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737984 DRESSING ++ CHANGE TRY CTRLLN DRESSING CHANGE TRAY OXQ UNK UNK
    737985 CASSETTE MEDI RESERVOIR SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL ASD, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1