BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHLORAPREP UNKNOWN

    MDR report key: 10739858 · Received October 27, 2020

    Report

    Report Number
    3004932373-2020-00094
    Event Type
    Injury
    Date Received
    October 27, 2020
    Date of Event
    November 12, 2020
    Report Date
    November 6, 2020
    Manufacturer
    CAREFUSION, INC
    Product Code
    KXG
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED BY F FURCI, S MARTINA, P FACCIONI, F FACCIONI, G SENNA, M CAMINATI (JOURNALISTS FOR AN ARTICLE PUBLISHED IN ORAL DISEASES). PROPHARMA DID REACH OUT TO OBTAIN 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

    MATERIAL NO.: UNKNOWN BATCH NO.: UNKNOWN. IT WAS THE PATIENT EXPERIENCED HYPERSENSITIVITY. VERBATIM: HYPERSENSITIVITY.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    MATERIAL NO.: UNKNOWN BATCH NO.: UNKNOWN. IT WAS THE PATIENT EXPERIENCED HYPERSENSITIVITY. VERBATIM: HYPERSENSITIVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1205342 CHLORAPREP UNKNOWN 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL KXG CAREFUSION, INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other