BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUNCTAL PLUG

    MDR report key: 17780448 · Received September 19, 2023

    Report

    Report Number
    MW5145878
    Event Type
    Malfunction
    Date Received
    September 19, 2023
    Report Date
    September 15, 2023
    Manufacturer
    UNKNOWN
    Product Code
    HNW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2023 - SCHIRMER'S TEST - 4MM OF WETTING OU. TEMPORARY PUNCTAL PLUGS PLACED THAT DAY. PT SAYS THAT THEY DID NOT HELP HER DRY EYE SYMPTOMS. PAE REPORTED BY HCP, WHO DOES NOT CONSENT TO FOLLOW UP. (B)(6). REFERENCE REPORT: MW5145879.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1801282 PUNCTAL PLUG DILATOR, LACHRYMAL HNW UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown