BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDLINE INDUSTRIES, INC.

    MDR report key: 10963417 · Received December 7, 2020

    Report

    Report Number
    1423395-2020-00041
    Event Type
    Injury
    Date Received
    December 7, 2020
    Date of Event
    September 30, 2020
    Report Date
    January 14, 2021
    Manufacturer
    MEDLINE INDUSTRIES INC.
    Product Code
    OJK
    UDI-DI
    10193489259063
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE REPORTING FACILITY INDICATING THAT THE LOT NUMBER ORIGINALLY REPORTED TO THE PACK MANUFACTURER WAS INCORRECT. THE CORRECT LOT NUMBER HAS BEEN INPUTTED INTO SECTION D4. THE REPORTING FACILITY RETURNED FOURTEEN (14) PACKS FROM THE CORRECTED LOT NUMBER FOR EVALUATION. EXAMINATION OF THE PACKS FOUND NO HOLES, TEARS, OR PUNCTURES IN THE BREATHER POUCH WHICH COULD COMPROMIS STERILITY. THE RETURNED SAMPLES WERE OPENED AND EXAMINED FOR PARTICULATE, MISSING COMPONENTS, OR OTHER POSSIBLE PRODUCTION ASSEMBLY ISSUES AND NONE WERE FOUND. A ROOT CAUSE FOR THE REPORTED INCIDENT WAS UNABLE TO BE DETERMINED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE ANOTHER SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED BY THE PACK MANUFACTURER. REPORTEDLY, THE PATIENT WAS DIAGNOSED WITH ENDOPTHALMITIS FOR WHICH AN UNSPECIFIED ANTIBIOTIC THERAPY WAS RECEIVED. THE PATIENT REPORTEDLY BEGAN TO EXPERIENCE SYMPTOMS OF THE INFECTION ON (B)(6) 2020. THE CATARACT SURGERY WAS PERFORMED ON (B)(6) 2020. THE PATIENT REPORTEDLY DIED SOMETIME IN (B)(6) 2020 AND NO CAUSE OF DEATH WAS PROVIDED. AT THIS TIME, NO INFORMATION HAS BEEN RECEIVED TO INDICATE THAT THE REPORTED PRODUCT PROBLEM/ISSUE CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE ANOTHER SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT FOLLOWING A CATARACT SURGERY WHERE THE PROCEDURE PACK WAS USED, THE PATIENT EXPERIENCED AN UNSPECIFIED INFECTION. REPORTEDLY, THE PATIENT WAS REFERRED TO A RETINAL SPECIALIST WHERE UNSPECIFIED CULTURES WERE DRAWN AND AN UNSPECIFIED ANTIBIOTIC TREATMENT WAS STARTED. THE PATIENT HAS REQUIRED FOLLOW-UP CARE FROM THE RETINAL SPECIALIST. NO ADDITIONAL INFORMATION WAS PROVIDED BY THE REPORTING FACILITY AND IT IS UNKNOWN WHAT COMPONENT(S) FROM THE PROCEDURE PACK WERE USED AT THE TIME OF THE CATARACT SURGERY. NO SAMPLE WAS RETURNED TO THE PACK MANUFACTURER FOR EVALUATION. A ROOT CAUSE FOR THE REPORTED INCIDENT WAS UNABLE TO BE DETERMINED. DUE TO THE REPORTED INFECTION AND THE NEED FOR MEDICAL INTERVENTION, THIS MEDWATCH IS BEING FILED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED AN UNSPECIFIED INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1428238 MEDLINE INDUSTRIES, INC. THE SURGERY CENTER CATARACT OJK MEDLINE INDUSTRIES INC. VAL002CATSD 20BBX711 10193489259063

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention