BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PTOSE UP

    MDR report key: 16437241 · Received February 23, 2023

    Report

    Report Number
    MW5115155
    Event Type
    Malfunction
    Date Received
    February 23, 2023
    Date of Event
    December 16, 2022
    Report Date
    February 17, 2023
    Manufacturer
    FCI OPHTHALMICS / FCI SAS
    Product Code
    HJZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SURGERY #2 WAS PERFORMED ON (B)(6) 2022 AND THE IMPLANT WAS REMOVED ON (B)(6) 2022 SECONDARY TO AN INFECTED FRONTALIS SLING OF THE LEFT EYE (MAY BE THE RT EYE AS THE TWO OPERATIVE REPORTS LIST RT EYE ON THE ORIGINAL SURGERY AND LT ON THE IMPLANT REMOVAL). PURULENT DRAINAGE WAS ALSO NOTED. THE CULTURE GREW 1+ STAPHYLOCOCCUS AUREUS WITHIN 24 HOURS OF THE SPECIMEN BEING SENT TO THE LAB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    753572 PTOSE UP CRUTCH, PTOSIS HJZ FCI OPHTHALMICS / FCI SAS 2201084

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other