BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IV++ SCIG 26G 14MM HIGH FLO

    MDR report key: 14357256 · Received May 10, 2022

    Report

    Report Number
    MW5109615
    Event Type
    Injury
    Date Received
    May 10, 2022
    Report Date
    April 29, 2022
    Manufacturer
    REPRO MED SYSTEMS, INC.
    Product Code
    FPA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    INDICATION: SELECTIVE DEFICIENCY OF IMMUNOGLOBULIN G [LGG] SUBCLASSES. PATIENT REPORTED LEAKING SOMETIMES DURING INFUSION AND SOMETIMES AFTERWARD. SHE IS ALREADY USING THE LONGEST NEEDLE SIZE AT 14MM, AND DOES NOT WANT TO INCREASE THE NUMBER OF SITES EITHER. NO ADVERSE EVENT REPORTED; UNKNOWN IF NEEDLES AVAILABLE FOR RETURN; UNKNOWN IF MD AWARE. NO FURTHER INFORMATION PROVIDED. PT ALSO REPORTS STOMACH/FLANK PAIN, COUGHING DURING AND/OR AFTER INFUSION, PHLEGM BUILD UP, HEADACHES, ITCHING, BRIGHT RED WELTS AT INFUSION SITES. THESE SYMPTOMS ARE IRREGULAR AND NO SPECIFIC PATTERN OF WHEN SHE EXPERIENCES THEM. NEEDLES USED TO INFUSE CUTAQUIG AT ABOVE DOSE AND FREQUENCY. REPORTED TO (B)(6)/CAREMARK BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    870945 IV++ SCIG 26G 14MM HIGH FLO SET, ADMINISTRATION, INTRAVASCULAR FPA REPRO MED SYSTEMS, INC. RMS32614

    Patients

    Seq Age Sex Outcome Treatment
    1 Female