BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCLERAL BUCKLING DEVICE

    MDR report key: 274721 · Received April 19, 2000

    Report

    Report Number
    274721
    Event Type
    Injury
    Date Received
    April 19, 2000
    Date of Event
    April 4, 2000
    Report Date
    April 17, 2000
    Manufacturer
    UNK
    Product Code
    LXP
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    PT HAD A SCLERAL BUCKLING PROCEDURE IN 1999 AT ANOTHER FACILITY, FOR RETINAL DETACHMENT. THE PT HAS HAD SEVERAL EPISODES OF POSTOP INFLAMMATION WITH RECURRENCE OF INFLAMMATORY TISSUE FROM THE ORBIT, AND MULTIPLE EXCISIONS OF RECURRING TISSUE. ON 4/4/00 THE PT UNDERWENT REMOVAL OF A 287 SCLERAL BUCKLE AND A 240 BAND. THE RETINA REMAINED ATTACHED, BUT THERE WAS EVIDENCE OF MULTIPLE AREAS OF NECROTIC TISSUE AND ONE AREA OF RED SPONGY TYPE TISSUE THAT WAS DISSECTED AND SENT TO PATHOLOGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCLERAL BUCKLING DEVICE SCLERAL BUCKLE DEVICE LXP UNK UNK UNK
    2 SCLERAL BUCKLING DEVICE SCLERAL BUCKLE DEVICE MTB UNK UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention