BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHLORAPREP UNKNOWN

    MDR report key: 12705764 · Received October 27, 2021

    Report

    Report Number
    3004932373-2021-00482
    Event Type
    Injury
    Date Received
    October 27, 2021
    Date of Event
    October 18, 2021
    Report Date
    December 16, 2021
    Manufacturer
    CAREFUSION 213, LLC 0113
    Product Code
    OJU
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED BY THE MHRA UK. 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. H3 OTHER TEXT: SEE NARRATIVE BELOW.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT HAD AN ALLERGIC REACTION TO CHLORAPREP. VERBATIM: "ALSO SINCE COVID VACCINE I HAVE SOME SORT OF ALLERGY AGAINST HAIR DYE." "RASH AND SWELLING IN THE NECK UNDER CHIN" "RASH AND SWELLING IN THE NECK UNDER CHIN. VERY ITCHY RASH AND SWOLLEN UNDER CHIN. I HAD A BIOPSY ON MY THYROID AND THIS LOTION WAS USED TO PREP THE SKIN BEFORE THE NEEDLE WENT IN. AFTER 24HRS THIS AWFUL RASH AND SWELLING APPEARED IT WAS VERY FRIGHTENING AND UNCOMFORTABLE FOR 4/5 DAYS."

    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 PATIENT HAD AN ALLERGIC REACTION TO CHLORAPREP. VERBATIM: "ALSO SINCE COVID VACCINE I HAVE SOME SORT OF ALLERGY AGAINST HAIR DYE." "RASH AND SWELLING IN THE NECK UNDER CHIN" "RASH AND SWELLING IN THE NECK UNDER CHIN. VERY ITCHY RASH AND SWOLLEN UNDER CHIN. I HAD A BIOPSY ON MY THYROID AND THIS LOTION WAS USED TO PREP THE SKIN BEFORE THE NEEDLE WENT IN. AFTER 24HRS THIS AWFUL RASH AND SWELLING APPEARED IT WAS VERY FRIGHTENING AND UNCOMFORTABLE FOR 4/5 DAYS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1603024 CHLORAPREP UNKNOWN 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL OJU CAREFUSION 213, LLC 0113 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other