BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESURE SEALANT

    MDR report key: 7293906 · Received February 23, 2018

    Report

    Report Number
    3008477155-2018-00001
    Event Type
    Injury
    Date Received
    February 23, 2018
    Report Date
    January 25, 2018
    Manufacturer
    OCULAR THERAPEUTIX
    Product Code
    PFZ
    PMA / PMN Number
    P130004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DESPITE MULTIPLE REQUESTS FOR ADDITIONAL INFORMATION, OCULAR THERAPEUTIX (OTX) HAS NOT RECEIVED ADDITIONAL INFORMATION. OTX DOES NOT HAVE ANY INFORMATION ON THE PHYSICIAN(S) WHO APPLIED RESURE, THE PATIENTS WHO MAY HAVE EXPERIENCED ENDOPHTHALMITIS, IF SERIOUS INJURY OCCURRED, OR IF THE PHYSICIAN(S) BELIEVE RESURE SEALANT CAUSED OR CONTRIBUTED TO THE INJURY. BASED ON THIS INFORMATION, THERE IS INSUFFICIENT INFORMATION FOR US TO DETERMINE IF THERE IS A CHANGE TO THE RISK PROFILE OF RESURE. FOLLOW-UP REPORTS WILL BE SUBMITTED IN ACCORDANCE WITH 21 CFR PART 803.56 IF ADDITIONAL INFORMATION IS OBTAINED.

    Description of Event or Problem · 1

    IN FOLLOW-UP TO A MEDICAL INFORMATION REQUEST, A PHYSICIAN REPORTED THAT THERE WERE TWO PATIENTS WITH ENDOPHTHALMITIS AND BOTH PATIENTS WERE TREATED WITH RESURE SEALANT. OTX WAS UNABLE TO COLLECT ADDITIONAL INFORMATION DESPITE MULTIPLE ATTEMPTS TO FOLLOW-UP WITH THE PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135634 RESURE SEALANT RESURE SEALANT PFZ OCULAR THERAPEUTIX

    Patients

    Seq Age Sex Outcome Treatment
    1 Other