BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHLORAPREP ONE STEP HI-LITE ORANGE

    MDR report key: 13316015 · Received January 21, 2022

    Report

    Report Number
    3004932373-2022-00013
    Event Type
    Injury
    Date Received
    January 21, 2022
    Date of Event
    January 12, 2022
    Report Date
    February 4, 2022
    Manufacturer
    CAREFUSION 213, LLC 0113
    Product Code
    KXG
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6) INITIAL EMDR SUBMISSION. A FOLLOW UP EMDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4).

    Additional Manufacturer Narrative · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED BY THE CARE SURGERY CENTER NEW BRUNSWICK. PRIME VIGILANCE 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENTS ARE HAVING A REACTION TO CHLORAPREP. VERBATIM: CHLORAPREP PART NO.: 930815 LOT NO.: UNKNOWN". COMPLAINT RECEIVED VIA PHONE CALL. IT WAS REPORTED "PATIENTS ARE HAVING REACTIONS TO THE ORANGE CHLORAPREP. 2 PATIENTS HAVE HAD SEVERE SKIN REACTIONS AND ARE ITCHING, WHEREVER IT WAS ORANGE." PART NO.: 930815 LOT NO.: UNKNOWN".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENTS ARE HAVING A REACTION TO CHLORAPREP. VERBATIM: CHLORAPREP PART NO.: 930815 LOT NO.: UNKNOWN". COMPLAINT RECEIVED VIA PHONE CALL IT WAS REPORTED "PATIENTS ARE HAVING REACTIONS TO THE ORANGE CHLORAPREP. 2 PATIENTS HAVE HAD SEVERE SKIN REACTIONS AND ARE ITCHING, WHEREVER IT WAS ORANGE." PART NO.: 930815 LOT NO.: UNKNOWN".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682837 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 Unknown Other