BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHLORAPREP UNKNOWN

    MDR report key: 12689904 · Received October 25, 2021

    Report

    Report Number
    3004932373-2021-00478
    Event Type
    Injury
    Date Received
    October 25, 2021
    Date of Event
    October 12, 2021
    Report Date
    December 8, 2021
    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

    NO ADDITIONAL INFORMATION WAS PROVIDED BY UNITED THERAPEUTICS. 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 THE PATIENT WAS ALLERGIC TO CHLORAPREP. VERBATIM: THIS UNITED STATES CASE IS A SOLICITED REPORT RECEIVED ON (B)(6) 2021 FROM A CONSUMER'S HUSBAND FROM A PATIENT SUPPORT PROGRAM VIA ACCREDO SPECIALTY PHARMACY. THIS 70 YEAR OLD, 214 LB, FEMALE PATIENT BEGAN THERAPY WITH REMODULIN (TREPROSTINIL SODIUM, CONCENTRATION 2.5 MG/ML), ON (B)(6) 2021 FOR PRIMARY PULMONARY ARTERIAL HYPERTENSION. THE CURRENT DOSE WAS REPORTED 0.0395 G/KG, CONTINUOUS VIA INTRAVENOUS (IV) ROUTE. ON AN UNREPORTED DATE IN 2021, THE PATIENT WAS ALLERGIC TO THE CHLORAPREP (DERMATITIS CONTACT).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS ALLERGIC TO CHLORAPREP. VERBATIM: THIS UNITED STATES CASE IS A SOLICITED REPORT RECEIVED ON (B)(6) 2021 FROM A CONSUMER'S HUSBAND FROM A PATIENT SUPPORT PROGRAM VIA (B)(6) PHARMACY. THIS (B)(6) YEAR OLD, (B)(6) LB, FEMALE PATIENT BEGAN THERAPY WITH REMODULIN (TREPROSTINIL SODIUM, CONCENTRATION 2.5 MG/ML), ON 21 JUL 2021 FOR PRIMARY PULMONARY ARTERIAL HYPERTENSION. THE CURRENT DOSE WAS REPORTED 0.0395 G/KG, CONTINUOUS VIA INTRAVENOUS (IV) ROUTE. ON AN UNREPORTED DATE IN 2021, THE PATIENT WAS ALLERGIC TO THE CHLORAPREP (DERMATITIS CONTACT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1588010 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 70 YR Female Other