BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREVANTICS DEVICE SWAB

    MDR report key: 8497487 · Received April 9, 2019

    Report

    Report Number
    2411192-2019-00001
    Event Type
    Injury
    Date Received
    April 9, 2019
    Date of Event
    February 13, 2019
    Report Date
    March 13, 2019
    Manufacturer
    PROFESSIONAL DISPOSABLES INTERNATIONAL INC.
    Product Code
    LKB
    PMA / PMN Number
    K132380
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2019 PDI WAS INFORMED THAT A PATIENT EXPERIENCED AN ANAPHYLAXIS REACTION ON (B)(6) 2019 SHORTLY AFTER HER PERMA CATH ACCESS HUB WAS PREPPED FOR DIALYSIS USING THE PREVANTICS ANTISEPTIC DEVICE SWAB. ACCORDING TO THE FACILITY ADMINISTRATOR, THE PATIENT'S INITIAL SYMPTOM WAS SWELLING, FOLLOWED BY THE PATIENT CODING WHICH REQUIRED RESUSCITATION FOR APPROX. 8 MINUTES. PATIENT WAS INTUBATED WHILE IN THE ICU. PROVIDERS DID EXPERIENCE DIFFICULTY PLACING THE INTUBATION TUBE DUE TO THROAT SWELLING. PATIENT SPENT A "COUPLE" OF DAYS IN THE ICU AND WAS EXTUBATED PRIOR TO BEING MOVED TO A STEP-DOWN UNIT. PATIENT HAS BEEN DISCHARGED FROM THE HOSPITAL AND IS CURRENTLY STABLE. DATE OF DISCHARGE IS UNKNOWN. NO CHANGES IN PATIENT'S CARE/CONDITION SINCE THE ANAPHYLAXIS REACTION, CONTINUES WITH DIALYSIS 3X A WEEK. PATIENT WAS NOTED AS HAVING SKIN ALLERGY TO CHG ON HER MEDICAL CHART PRIOR TO HER DIALYSIS TREATMENT AND USE OF THIS PRODUCT. UNKNOWN IF SHE HAS ANY OTHER ALLERGIES. FACILITY ADMINISTRATOR ADDED THAT PATIENTS WITH KNOWN CHG ALLERGIES ARE PREPPED WITH ALCOHOL PREP PADS ONLY, AND THEREFORE THE PERMA CATH ACCESS HUB SHOULD NOT BE CLEANED WITH CHG PRODUCTS PRIOR TO DIALYSIS TREATMENT. FACILITY ADMINISTRATOR ADVISED THAT THE PREVANTICS PRODUCT WAS USED TO CLEAN THE PATIENT'S HUB DURING PREVIOUS DIALYSIS TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289767 PREVANTICS DEVICE SWAB CHG 3.15% AND IPA 70% SWAB LKB PROFESSIONAL DISPOSABLES INTERNATIONAL INC. 11801707

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization