BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INF SET QUICK SET

    MDR report key: 14022118 · Received April 5, 2022

    Report

    Report Number
    MW5108797
    Event Type
    Malfunction
    Date Received
    April 5, 2022
    Report Date
    March 24, 2022
    Manufacturer
    UNK
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SPONTANEOUS COMMUNICATION FROM RN (B)(6) FROM PRESCRIBER'S OFFICE; REPORTS PATIENT IS USING THE QUICKSET AND HER SITES DO NOT STAY IN VERY GOOD, SINCE PATIENT STOPPED USING SKIN PREP DUE TO SKIN REACTIONS BACK IN DECEMBER. REPORT FOR SKIN REACTION ISSUE WAS ALREADY FILED BACK IN DECEMBER. MD IS REQUESTING ASSISTANCE WITH BETTER SUPPLY OPTIONS FOR PATIENT'S SUBCUTANEOUS REMODULIN ADMINISTRATION. NO ADVERSE EVENT DOCUMENTED. DID THE REPORTED PRODUCT FAULT OCCUR WHILE IN USE WITH THE PT? YES; DID THE PRODUCT ISSUE CAUSE OR CONTRIBUTE TO PT OR CLINICAL INJURY? NO; IS THE ACTUAL DEVICE AVAILABLE FOR INVESTIGATION? UNK; DID WE [MFR] REPLACE THE DEVICE? UNK; DID THE PT HAVE A BACKUP DEVICE THEY WERE ABLE TO SWITCH TO? UNK. REPORTED TO (B)(6) BY HEALTH PROFESSIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    940095 INF SET QUICK SET SET, ADMINISTRATION, INTRAVASCULAR FPA UNK UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Female