BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHLORAPREP UNKNOWN

    MDR report key: 12816936 · Received November 15, 2021

    Report

    Report Number
    3004932373-2021-00492
    Event Type
    Injury
    Date Received
    November 15, 2021
    Date of Event
    February 3, 2021
    Report Date
    November 16, 2021
    Manufacturer
    CAREFUSION 213, LLC 0113
    Product Code
    OJU
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED BY THE EVELINA HOSPITAL. 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.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A VERY PREM BABY REACTION RESULTING IN BURNS FROM CHLOHEXIDINE AND ALCOHOL. VERBATIM: HAD A VERY PREM BABY LAST WEEK WITH BURNS FROM CHLOHEXIDINE AND ALCOHOL. NO OTHER INFORMATION CURRENTLY AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A VERY PREM BABY REACTION RESULTING IN BURNS FROM CHLORHEXIDINE AND ALCOHOL. VERBATIM: HAD A VERY PREM BABY LAST WEEK WITH BURNS FROM CHLORHEXIDINE AND ALCOHOL. NO OTHER INFORMATION CURRENTLY AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1711121 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