BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHLORAPREP UNKNOWN

    MDR report key: 13653547 · Received March 2, 2022

    Report

    Report Number
    3004932373-2022-00061
    Event Type
    Injury
    Date Received
    March 2, 2022
    Date of Event
    February 18, 2022
    Report Date
    May 3, 2022
    Manufacturer
    CAREFUSION 213, LLC 0113
    Product Code
    OJU
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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).

    Additional Manufacturer Narrative · 0

    PHOTOS WERE AVAILABLE FOR EVALUATION. VISUAL EXAMINATION OF THE PHOTOS SHOW AN APPARENT REACTION TO THE PATIENT'S SKIN. UNFORTUNATELY, WITHOUT THE SAMPLE OR PHOTO OF THE SAMPLE USED, BD IS UNABLE TO VERIFY THE REPORTED ISSUE AS IT RELATES TO THE CHLORAPREP APPLICATOR. IN ADDITION, A DEFINITIVE ROOT CAUSE COULD NOT BE DEFINED AT THIS TIME. A PRODUCTION RECORD REVIEW COULD NOT BE COMPLETED WITHOUT THE BATCH/LOT INFORMATION AVAILABLE. NO FURTHER ACTIONS ARE REQUIRED. THIS FAILURE WILL CONTINUE TO BE TRACKED AND TRENDED. H3 OTHER TEXT : SEE NARRATIVE BELOW

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENTS EXPERIENCED SKIN IRRITATION. ADDITIONAL CASE OPENED FROM (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENTS EXPERIENCED SKIN IRRITATION VERBATIM: ADDITIONAL CASE OPENED FROM ES-BD-22-000049 (PR 4529717) WED (B)(6) 202210:29 AM GOOD AFTERNOON TO EVERYONE, TODAY I HAVE BEEN WITH THE OR SUPERVISOR GETTING SOME MORE DATA ABOUT THESE THREE INCIDENTS. THEY DON¿T KNOW THE EXACT DATE OF EACH ONE OF THE INCIDENTS BUT THEY WERE FROM DECEMBER. THE ADVERSE EVENTS HAVE BEEN SKIN IRRITATIONS AFTER DIFFERENT ORTHOPEDIC SURGERIES (HAND AND FOOT), STARTING AROUND 2 DAYS AFTER THE SURGERY AND WHEN THEY DID A POST-OPERATIVE REVISION WERE ALMOST GONE. THE PATIENTS DIDN¿T NEED ANY TREATMENT. I AM ATTACHING YOU THE PICTURES THAY HAVE SENT ME. THEY ARE ALSO INVESTIGATING OF THESE CASES COULD BE INDUCED BY OTHER PRODUCTS SUCH US THE POST-OP DRESSING OR THE ADHESIVE FROM THE DRAPES AND GOWNS. DURING TODAY¿S VISIT WE SPOKE WITH THE ORTHOPEDIC SURGEON WHO IS GETTING THE INFO ABOUT THESE EVENTS AND SHE TOLD ME THAT DURING JANUARY AND FEBRUARY THEY HAD SOME NEW EVENTS SIMILAR TO THESE (SKIN IRRITATIONS). THESE NEW EVENTS HAVE BEEN BETWEEN 3 AND 5. SHE WASN¿T ABLE TO SPECIFY. I HAVE REQUESTED THEM TO CHECK IF THERE ARE NEW CASES SPECIFYING THE DATE, THE SURGICAL PROCEDURE, THE USEFUL INFO RELATED TO THE EVENT ETC.. SHOULD I DO ONE REPORT FOR THESE NEW EVENTS OR ONE FOR EACH REPORT?

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1597926 CHLORAPREP UNKNOWN 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