BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUSTOM PAK

    MDR report key: 2190824 · Received July 28, 2011

    Report

    Report Number
    3002037047-2011-00046
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    June 22, 2011
    Report Date
    June 28, 2011
    Manufacturer
    ALCON - BELGIUM/ S.A.ALCON-COUVREUR N.V.
    Product Code
    KYG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLES WERE RECEIVED FOR EVALUATION. REVIEW OF THE BATCH RELATED DOCUMENTATION OF THIS SPECIFIC LOT SHOWED NO IRREGULARITIES. NO REMARKS WERE MADE DURING MANUFACTURING WHICH COULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. THE STERILIZATION CYCLE WAS CHECKED FOR THIS SPECIFIC LOT AND NO ABNORMALITIES WERE NOTED. THE PRODUCT WAS RELEASED ACCORDING TO THE MANUFACTURER'S SPECIFICATIONS. THE ROOT CAUSE COULD NOT BE IDENTIFIED. (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL PHARMACIST REPORTED TWO CASES OF SEVERE ENDOPHTHALMITIS THAT APPEARED ONE DAY POSTOPERATIVELY. THE SURGERIES WERE PERFORMED ON DIFFERENT DAYS BY THE SAME SURGEON, SAME OPERATING ROOM, AND BOTH CASES LASTED LESS THAN 30 MINS. THE CUSTOMER INDICATED THE SAME LOT FOR THE PROBE AND CUSTOM PACK WERE USED IN EACH PROCEDURE. CURRENT PT STATUS IS UNK. ADDITIONAL INFO HAS BEEN REQUESTED. THIS IS THE THIRD OF FOUR MEDICAL DEVICE REPORTS FOR THIS FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUSTOM PAK CONVENIENCE KIT KYG ALCON - BELGIUM/ S.A.ALCON-COUVREUR N.V. CUSTOM PAK 263409

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ACCURUS SYSTEM| TOTAL PLUS 23GA PAK