BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHLORAPREP ONE STEP HI- LITE ORANGE

    MDR report key: 11844769 · Received May 18, 2021

    Report

    Report Number
    3004932373-2021-00244
    Event Type
    Malfunction
    Date Received
    May 18, 2021
    Date of Event
    April 21, 2021
    Report Date
    May 18, 2021
    Manufacturer
    CAREFUSION 213, LLC 0113
    Product Code
    KXG
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    MATERIAL NO.: 930415. BATCH NO.: UNKNOWN. IT WAS REPORTED BY THE DISTRIBUTOR THAT THE PATIENT DEVELOPED POST OPERATIVE SKIN AND SOFT TISSUE INFECTION. PER MANUFACTURER NOTICE: THE DOCTOR REPORTS THAT A FEW DAYS AFTER A [OMITTED] PATIENT HAD A LAPAROSCOPIC TUBAL LIGATION PROCEDURE THE PATIENT DEVELOPED A SERIOUS POST OPERATIVE SKIN AND SOFT TISSUE INFECTION. THE PATIENT WAS TREATED WITH ANTIBIOTICS AND ALSO WENT TO THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738207 CHLORAPREP ONE STEP HI- LITE ORANGE 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL KXG CAREFUSION 213, LLC 0113 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Other