BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHLORAPREP UNKNOWN

    MDR report key: 12030417 · Received June 20, 2021

    Report

    Report Number
    3004932373-2021-00293
    Event Type
    Injury
    Date Received
    June 20, 2021
    Date of Event
    June 7, 2021
    Report Date
    June 8, 2021
    Manufacturer
    CAREFUSION 213, LLC 0113
    Product Code
    OJU
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE LITERATURE ARTICLE THAT THE PATIENT WAS DIAGNOSED WITH ENDOPHTHALMITIS AND DEVELOPED PAIN, REDNESS, AND DECREASED VISION AFTER USE OF PVI. A HEALTHY [OMITTED] WITH A HISTORY OF NEOVASCULAR AGERELATED MACULAR DEGENERATION (AMD) WHO HAD UNDERGONE APPROXIMATELY 131 INTRAVITREAL ANTI-VEGF INJECTIONS TO BOTH EYES RECEIVED AN INTRAVITREAL INJECTION OF AFLIBERCEPT IN THE RIGHT EYE FOR PERSISTENT SUBRETINAL FLUID. DURING THE INJECTION, BOTH THE PATIENT AND PHYSICIAN WORE A MASK. THE IVI INJECTION TECHNIQUE CONSISTED OF INFEROTEMPORAL SUBCONJUNCTIVAL LIDOCAINE, FOLLOWED BY TOPICAL 5% POVIDONE-IODINE (PVI) EYELID SCRUBS AND TOPICAL PVI TO THE CONJUNCTIVA FORNIX. AFTER A LID SPECULUM WAS PLACED, ADDITIONAL CONJUNCTIVAL PVI WAS APPLIED, FOLLOWED BY A TOPICAL PVI-SOAKED PLEDGET HELD ON THE INJECTION SITE FOR 15 SECONDS PRIOR TO INJECTION. THE PATIENT PRESENTED TWO DAYS LATER WITH RIGHT EYE PAIN, REDNESS, AND A DECREASE IN VISION. AT PRESENTATION, BEST CORRECTED VISUAL ACUITY (BCVA) OF THE RIGHT EYE WAS HAND MOTION (DECREASED FROM 20/25) AND EXAMINATION REVEALED CONJUNCTIVAL INJECTION, HYPOPYON, DENSE VITRITIS, AND INTRARETINAL HEMORRHAGES (FIG. 1). THE PATIENT WAS DIAGNOSED WITH ENDOPHTHALMITIS AND UNDERWENT A VITREOUS TAP AND INJECTION OF INTRAVITREAL VANCOMYCIN (1 MG/0.1 ML), CEFTAZIDIME (2.25 MG/0.1 ML), AND TRIAMCINOLONE ACETONIDE (0.40 MG/0.1 ML). NO ORAL ANTIBIOTICS WERE PRESCRIBED. BECAUSE OF PERSISTENT VITREOUS OPACITIES AND INFLAMMATION, NINE DAYS AFTER INITIAL PRESENTATION THE PATIENT UNDERWENT PARS PLANA VITRECTOMY WITH INJECTION OF TRIAMCINOLONE. SIX WEEKS AFTER INITIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    927128 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 74 YR Other