BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHLORAPREP UNKNOWN

    MDR report key: 12815725 · Received November 15, 2021

    Report

    Report Number
    3004932373-2021-00491
    Event Type
    Injury
    Date Received
    November 15, 2021
    Date of Event
    November 2, 2021
    Report Date
    November 4, 2021
    Manufacturer
    CAREFUSION 213, LLC 0113
    Product Code
    KXG
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    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). NO ADDITIONAL INFORMATION WAS PROVIDED BY THE DEPARTMENT OF OPHTHALMOLOGY, (B)(6). 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 THERE MIGHT BE A POTENTIAL REACTION DURING USE OF UNKNOWN POVIDONE-IODINE SOLUTION. VERBATIM: TRENDS IN ENDOPHTHALMITIS ASSOCIATED WITH INTRAVITREAL INJECTION OF ANTI-VEGF AGENTS AT A TERTIARY REFERRAL CENTER REYES-CAPO D.P., YANNUZZI N.A., SMIDDY W.E., FLYNN H.W. OPHTHALMIC SURGERY LASERS AND IMAGING RETINA (2021) 52:6 (319-326). DATE OF PUBLICATION: 1 JUN 2021. PER DCHU THIS LOOKS LIKE IT WAS RELATED TO A POTENTIAL REACTION (ENDOPHTHALMITIS) DURING THE USE OF THE UNKNOWN POVIDONE-IODINE SOLUTION. BECAUSE THIS IS A POTENTIAL INFECTION INSIDE OF THE EYE, I AM INCLUDING (B)(4) IN THIS COMMUNICATION AS THIS MAY WARRANT A FAR REPORT NEEDED THAT NEEDS TO BE SUBMITTED. I¿M HOPING THEY CAN CONFIRM IF THIS IS INDEED THE NEXT STEPS. (B)(4), MAY YOU PLEASE TAKE A LOOK AT THIS RECORD AND CONFIRM IF IT QUALIFIES FOR FAR/MDR REPORTABILITY. I¿LL MOVE FORWARD BASED ON YOUR DIRECTION. THANKS IN ADVANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1711310 CHLORAPREP UNKNOWN 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL KXG CAREFUSION 213, LLC 0113 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other