BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHLORAPREP UNKNOWN

    MDR report key: 12971469 · Received December 9, 2021

    Report

    Report Number
    3004932373-2021-00532
    Event Type
    Injury
    Date Received
    December 9, 2021
    Date of Event
    November 3, 2021
    Report Date
    December 9, 2021
    Manufacturer
    CAREFUSION 213, LLC 0113
    Product Code
    OJU
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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). NO ADDITIONAL INFORMATION WAS PROVIDED BY THE CANADIAN HEALTH AUTHORITY. PRIMEVIGILANCE 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 A REACTION FROM CHLORAPREP. VERBATIM: OEDEMA PERIPHERAL [OEDEMA PERIPHERAL], ERYTHEMA [ERYTHEMA], RASH [RASH]. CASE DESCRIPTION: CASE REFERENCE NUMBER (B)(4). (BD ID:) IS A SPONTANEOUS CASE INITIALLY RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA CANADIAN HEALTH AUTHORITY ((B)(4)) ON (B)(6) 2021 AND CONCERNS A (B)(6) FEMALE PATIENT. CHLORHEXIDINE (B)(4). DEAR COLLEAGUES KIND REMINDER FOR THE EMAIL BELOW SINCE THE BD ID IS STILL NOT PROVIDED AND THE CASE NEEDS TO BE SUBMITTED TO (B)(6). ANY UNAUTHORIZED DISSEMINATION OR COPYING OF THIS E-MAIL MESSAGE AND ANY USE OR DISCLOSURE OF INFORMATION CONTAINED IN IT IS STRICTLY PROHIBITED AND MAY BE ILLEGAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1870482 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 56 YR Unknown Other