BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CHLORHEXIDINE

    MDR report key: 13502727 · Received February 9, 2022

    Report

    Report Number
    3004932373-2022-00043
    Event Type
    Injury
    Date Received
    February 9, 2022
    Date of Event
    February 3, 2022
    Report Date
    June 6, 2024
    Manufacturer
    CAREFUSION 213, LLC 0113
    Product Code
    OJU
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    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).

    Additional Manufacturer Narrative · 0

    (B)(4) INITIAL EMDR SUBMISSION. A FOLLOW UP EMDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. IMDRF ANNEX E CODE HEALTH EFFECT ¿ E0402 HYPERSENSITIVITY/ALLERGIC REACTION IMDRF ANNEX F CODE HEALTH EFFECT ¿ IMPACT CODE: F25 UNANTICIPATED ADVERSE DEVICE EFFECT IMDRF ANNEX A CODE MEDICAL DEVICE PROBLEM CODE: A24 ADVERSE EVENT WITHOUT IDENTIFIED DEVICE. ADDENDUM: CORRECTION SUBMITTED TO INCLUDE IMDRF CODES NOT PROVIDED, AND TO IDENTIFY THE PRODUCT WAS NOT A CHLORAPREP DEVICE AS REPORTED IN THE INITIAL MDR. THIS COMPLAINT WILL BE CANCELLED IN OUR SYSTEM AS IT WAS ERRONEOUS.

    Description of Event or Problem · 0

    MATERIAL NO: UNKNOWN. BATCH NO: UNKNOWN. IT WAS REPORTED THAT REACTION TO CHLORAPREP CONTROLLED TRAIL. VERBATIM: SRG-IP-EXTERNAL REF# (B)(4) POSTOPERATIVE ANTI-INFLAMMATORY EFFICACY OF 2% SALINE RINSES AND A HERBAL- MOUTHWASH AFTER NON-SURGICAL PERIODONTAL THERAPY FOR THE MANAGEMENT OF PERIODONTAL INFLAMMATION IN YOUNG ADULTS WITH CHLORHEXIDINE ALLERGY: A RANDOMIZED CONTROLLED TRIAL. AL-ZAWAWI AS, SHAHEEN MY, DEVANG DD, ALDULAIJAN HA, BASUDAN AM. INT J DENT HYG. 2022 JAN 27. DOI: 10.1111/IDH.12583. ONLINE AHEAD OF PRINT.

    Description of Event or Problem · 0

    MATERIAL NO: UNKNOWN. BATCH NO: UNKNOWN. IT WAS REPORTED THAT REACTION TO CHLORAPREP CONTROLLED TRAIL. VERBATIM: SRG-IP-EXTERNAL REF# IN-BD-22-000038-POSTOPERATIVE ANTI-INFLAMMATORY EFFICACY OF 2% SALINE RINSES AND A HERBAL- MOUTHWASH AFTER NON-SURGICAL PERIODONTAL THERAPY FOR THE MANAGEMENT OF PERIODONTAL INFLAMMATION IN YOUNG ADULTS WITH CHLORHEXIDINE ALLERGY: A RANDOMIZED CONTROLLED TRIAL AL-ZAWAWI AS, SHAHEEN MY, DEVANG DD, ALDULAIJAN HA, BASUDAN AM. INT J DENT HYG. 2022 JAN 27. DOI: 10.1111/IDH.12583. ONLINE AHEAD OF PRINT. ADDENDUM: JOURNAL ARTICLE, "POSTOPERATIVE ANTI-INFLAMMATORY EFFICACY OF 2% SALINE RINSES AND A HERBAL- MOUTHWASH AFTER NON-SURGICAL PERIODONTAL THERAPY FOR THE MANAGEMENT OF PERIODONTAL INFLAMMATION IN YOUNG ADULTS WITH CHLORHEXIDINE ALLERGY. REVIEW OF THE ARTICLE SHOWS THAT BD CHLORAPREP (WHICH CONTAINS CHLORHEXIDINE) WAS NOT USED TO TREAT THE PATIENT. AS SUCH THERE WAS NO PATIENT COMPLICATION ASSOCIATED WITH CHLORAPREP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1850545 UNKNOWN CHLORHEXIDINE 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL OJU CAREFUSION 213, LLC 0113 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other