BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CHLORAPREP

    MDR report key: 12888845 · Received November 29, 2021

    Report

    Report Number
    3004932373-2021-00510
    Event Type
    Injury
    Date Received
    November 29, 2021
    Date of Event
    November 15, 2021
    Report Date
    November 30, 2021
    Manufacturer
    CAREFUSION 213, LLC 0113
    Product Code
    OJU
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 · 0

    MATERIAL NO: UNKNOWN , BATCH NO: UNKNOWN. IT WAS REPORTED THAT PATIENTS REACTION TO CHLORAPREP. VERBATIM: "...A (B)(6)-YEAR-OLD PUERPERA (GRAVIDA 1, PARA 1) PRESENTED TO OUR OBSTETRICS AND GYNECOLOGY EMERGENCY UNIT COMPLAINING RECENT APPEARANCE OF FEVER, RIGHT UPPER QUADRANT (RUQ) PAIN EXACERBATED BY MOVEMENT, PELVIC PAIN, AND SMELLY LOCHIATIONS." "...CESAREAN DELIVERY WAS PERFORMED THROUGH PFANNENSTIEL INCISION, AFTER PREOPERATIVE POVIDONE-IODINE 10% SKIN PREPARATION, CHLORHEXIDINE VAGINAL CLEANSING".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1779404 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 Unknown Other