BEUDAMED
    FDA Adverse Event Other Summary report: N

    MIRAGEL SCLERAL BAUCKLING ELEMENT

    MDR report key: 29082 · Received December 27, 1995

    Report

    Report Number
    MW1008006
    Event Type
    Other
    Date Received
    December 27, 1995
    Date of Event
    February 28, 1995
    Report Date
    December 20, 1995
    Manufacturer
    MIRA, INC.
    Product Code
    HQJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    INTRUSION OF SCLERAL BUCKLING ELEMENT LEFT EYE. TWO VITRECTOMY SURGERIES HAVE BEEN PERFORMED 3/95 AND 4/95. PT HAS BEEN FITTED WITH A SCLERAL SHELL OS RETINAL REATTACHMENT SURGERY DONE ELSEWHERE IN 1984.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIRAGEL SCLERAL BAUCKLING ELEMENT SCLERAL BUCKLING ELEMENT HQJ MIRA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other