BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CHLORAPREP

    MDR report key: 11625645 · Received April 6, 2021

    Report

    Report Number
    3004932373-2021-00174
    Event Type
    Injury
    Date Received
    April 6, 2021
    Date of Event
    March 24, 2021
    Report Date
    April 7, 2021
    Manufacturer
    CAREFUSION 213, LLC 0113
    Product Code
    OJU
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PR (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

    MATERIAL NO.: UNKNOWN. BATCH NO.: UNKNOWN. IT WAS REPORTED PATIENT EXPERIENCED ADVERSE REACTIONS INCLUDING ARTHRALGIA, ARTHRITIS, CONCUSSION, COUGH, DRUG HYPERSENSITIVITY, DRUG INEFFECTIVE, FALL, FATIGUE, JUVENILE IDIOPATHIC ARTHRITIS, NASOPHARYNGITIS, OFF LABEL USE, RHINORRHOEA, SOMNOLENCE. ARTHRALGIA V.23.1. ARTHRITIS V.23.1. CONCUSSION V.23.1. COUGH V.23.1. DRUG HYPERSENSITIVITY V.23.1. DRUG INEFFECTIVE V.23.1. FALL V.23.1. FATIGUE V.23.1. JUVENILE IDIOPATHIC ARTHRITIS V.23.1. NASOPHARYNGITIS V.23.1. OFF LABEL USE V.23.1. RHINORRHOEA V.23.1. SOMNOLENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514764 UNKNOWN CHLORAPREP 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL OJU CAREFUSION 213, LLC 0113 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Other