BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHLORAPREP UNKNOWN

    MDR report key: 11628093 · Received April 7, 2021

    Report

    Report Number
    3004932373-2021-00177
    Event Type
    Injury
    Date Received
    April 7, 2021
    Date of Event
    March 25, 2021
    Report Date
    April 6, 2021
    Manufacturer
    CAREFUSION 213, LLC 0113
    Product Code
    KXG
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) INITIAL EMDR SUBMISSION. A FOLLOW UP EMDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. IMDRF ANNEX E CODE HEALTH EFFECT: CLINICAL CODE: (B)(4). IMDRF ANNEX A CODE MEDICAL DEVICE PROBLEM CODE: (B)(4). NO ADDITIONAL INFORMATION WAS PROVIDED BY A PHARMACIST VIA HEALTH AUTHORITY. 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 · 1

    IT WAS REPORTED APPLICATION SITE REDNESS, APPLICATION SITE BURNING, APPLICATION SITE PURITIS, AND APPLICATION SITE ITCHING. MEDICAL HISTORY WAS NOT REPORTED. CONCOMITANT PRODUCTS INCLUDED ERBITUX (CETUXIMAB) INTRAVENOUSLY, *INTRAVENOUS FOLFIRI (FLUOROURACIL, FOLINIC ACID, IRINOTECAN) ORAL PARACETAMOL, ORAL CANDESARTAN AND ORAL PREGABALIN. INDICATIONS AND DOSING DETAILS WERE NOT PROVIDED.* ON AN UNSPECIFIED DATE IN (B)(6) 2019, THE PATIENT WAS PREPPED WITH CHLORAPREP AT AN UNREPORTED DOSE AND FREQUENCY, APPLIED TOPICALLY FOR INFECTION PROPHYLAXIS. ON UNSPECIFIED DATE(S) IN (B)(6) 2019, AFTER BEING PREPPED WITH THE PRODUCT, THE PATIENT EXPERIENCED APPLICATION SITE ERYTHEMA*/REDNESS*, APPLICATION SITE BURNING, AND APPLICATION SITE PRURITUS*/ITCHING, ALL LOCATED ON DISINFECTED AREA.* ON UNSPECIFIED DATE(S) IN (B)(6) 2019, TREATMENT WITH THE PRODUCT WAS WITHDRAWN, AND THE APPLICATION SITE ERYTHEMA*/REDNESS*, APPLICATION SITE BURNING, AND APPLICATION SITE PRURITUS*/ITCHING* RESOLVED. NO ADDITIONAL INFORMATION WAS PROVIDED. ALL FOLLOW-UP INFORMATION IS BLENDED INTO THE CASE NARRATIVE ABOVE, WITH THE LATEST INFORMATION PRESENTED BETWEEN ASTERISKS (*). FOLLOW-UP INFORMATION WAS DOWNLOADED FROM HEALTH AUTHORITY ON (B)(6) 2021: VERBATIM OF THE ADVERSE EVENT OF APPLICATION SITE ERYTHEMA WAS UPDATED TO APPLICATION SITE ERYTHEMA/REDNESS, AND VERBATIM OF ADVERSE EVENT OF APPLICATION SITE PRURITUS WAS UPDATED TO APPLICATION SITE PRURITUS/ITCHING. ADDITIONAL CONCOMITANT MEDICATIONS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523940 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 69 YR Other