BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IPRISM CLIP

    MDR report key: 7533637 · Received May 22, 2018

    Report

    Report Number
    2032546-2018-00047
    Event Type
    Malfunction
    Date Received
    May 22, 2018
    Date of Event
    April 23, 2018
    Report Date
    June 15, 2018
    Manufacturer
    GLAUKOS CORPORATION
    Product Code
    HNH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO THE MANUFACTURER, AND IT WAS FOUND SEALED IN THE ORIGINAL PACKAGING. VISUAL INSPECTION OF THE RETURNED DEVICE CONFIRMED THE REPORTED ISSUE. A REVIEW OF PAST COMPLAINTS WAS CONDUCTED, AND THERE WAS NO INCREASE IN FREQUENCY FOR THE REPORTED COMPLAINT ISSUE. MFR# REFERENCE: (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED FOR EVALUATION. THE INVESTIGATION IS IN PROGRESS AND FINDINGS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. THE DEVICE HISTORY RECORDS WERE REVIEWED FOR THIS MANUFACTURING LOT AND THERE WERE NO NON-CONFORMITIES FOUND TO BE RELATED TO THE REPORTED EVENT. AS PART OF THE DEVICE HISTORY RECORDS REVIEW, THE STERILIZATION RECORDS FOR THIS LOT WERE REVIEWED AND THIS DEVICE LOT PASSED STERILITY TESTS. A COMPLAINT HISTORY REVIEW WAS COMPLETED FOR THIS LOT # AND NO SIMILAR ISSUES HAVE BEEN REPORTED. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT PRIOR TO PATIENT CONTACT, A FOREIGN MATERIAL WAS OBSERVED IN THE PACKAGING OF AN UNOPENED IPRISM CLIP. THERE WAS NO PATIENT CONTACT AS THE PRODUCT WAS NOT USED. A BACK UP PRODUCT WAS OPENED AND USED FOR THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377209 IPRISM CLIP RING, OPHTHALMIC (FLIERINGA) HNH GLAUKOS CORPORATION IPC05 9441442

    Patients

    Seq Age Sex Outcome Treatment
    1