BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHLORAPREP UNKNOWN

    MDR report key: 13315845 · Received January 21, 2022

    Report

    Report Number
    3004932373-2022-00010
    Event Type
    Injury
    Date Received
    January 21, 2022
    Date of Event
    January 4, 2022
    Report Date
    February 3, 2022
    Manufacturer
    CAREFUSION 213, LLC 0113
    Product Code
    KXG
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) INITIAL EMDR SUBMISSION. A FOLLOW UP EMDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4).

    Additional Manufacturer Narrative · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED BY ELITE SAFETY SCIENCES. PRIMEVIGILANCE DID REACH OUT TO OBTAIN MORE INFORMATION WITH NO SUCCESS. SHOULD ADDITIONAL INFORMATION BE AVAILABLE IN THE FUTURE, THE COMPLAINT WILL BE RE-OPENED AND INVESTIGATED. ALL COMPLAINTS ARE REVIEWED DURING MONTHLY QUALITY/SAFETY MEETINGS. IN ADDITION, COMPLAINTS ARE TRENDED AT MONTHLY QUALITY DATA ANALYST MEETINGS AND QUARTERLY PLANT MANAGEMENT REVIEW MEETINGS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS AN ADVERSE SKIN REACTION. EMAIL VERBATIM: ¿THIS UNITED STATES CASE IS A SOLICITED REPORT RECEIVED ON 04 JAN 2022 FROM A CONSUMER FROM A PATIENT SUPPORT PROGRAM VIA (B)(6) PHARMACY. THIS (B)(6) FEMALE PATIENT BEGAN THERAPY WITH REMODULIN (TREPROSTINIL SODIUM, CONCENTRATION 1.0 MG/ML), ON (B)(6) 2021 FOR PRIMARY PULMONARY ARTERIAL HYPERTENSION. THE CURRENT DOSE WAS REPORTED AS 0.008 G/KG, CONTINUOUS VIA INTRAVENOUS (IV) ROUTE. ON AN UNREPORTED DATE, THE PATIENT¿S DRESSING CHANGE KIT WITH CHOLORAPREP IRRITATED HER SKIN (DERMATITIS CONTACT). CO-SUSPECT MEDICATION INCLUDED CHLORAPREP (CHLORHEXIDINE) CONTINUED IN ADDITIONAL INFO SECTION.¿ NO FURTHER INFORMATION PROVIDED AT TIME OF ENTRY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS AN ADVERSE SKIN REACTION. EMAIL VERBATIM: ¿THIS UNITED STATES CASE IS A SOLICITED REPORT RECEIVED ON 04 JAN 2022 FROM A CONSUMER FROM A PATIENT SUPPORT PROGRAM VIA ACCREDO SPECIALTY PHARMACY. THIS 55 YEAR OLD, 143.3 LBS, FEMALE PATIENT BEGAN THERAPY WITH REMODULIN (TREPROSTINIL SODIUM, CONCENTRATION 1.0 MG/ML), ON (B)(6) 2021 FOR PRIMARY PULMONARY ARTERIAL HYPERTENSION. THE CURRENT DOSE WAS REPORTED AS (B)(4) G/KG, CONTINUOUS VIA INTRAVENOUS (IV) ROUTE. ON AN UNREPORTED DATE, THE PATIENT¿S DRESSING CHANGE KIT WITH CHOLORAPREP IRRITATED HER SKIN (DERMATITIS CONTACT). CO-SUSPECT MEDICATION INCLUDED CHLORAPREP (CHLORHEXIDINE CONTINUED IN ADDITIONAL INFO SECTION...¿ NO FURTHER INFORMATION PROVIDED AT TIME OF ENTRY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610860 CHLORAPREP UNKNOWN 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL KXG CAREFUSION 213, LLC 0113 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female Other