BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CHLORAPREP

    MDR report key: 13395017 · Received January 31, 2022

    Report

    Report Number
    3004932373-2022-00016
    Event Type
    Injury
    Date Received
    January 31, 2022
    Date of Event
    January 21, 2022
    Report Date
    January 26, 2022
    Manufacturer
    CAREFUSION 213, LLC 0113
    Product Code
    OJU
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (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# UNKNOWN. BATCH# UNKNOWN. IT WAS REPORTED THAT THERE WAS AN ADVERSE REACTION. VERBATIM: (B)(6) - SUMMARY OF REPORTED ADVERSE REACTIONS. RECEIVED VIA: EMAIL. EXTERNAL REFERENCE # (B)(4). ON 25/01/2022: FINAL CIOMS FOR CASE (B)(4) (BD ID: (B)(4)) (LRD (B)(6)2022). KINDLY NOTE THAT THE CASE WAS EXCHANGED WITH (B)(6) ON 14-JAN-2022, AND SUBMITTED ON 19-JAN-2022 TO (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1403182 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