BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCRAPER MEMBRANE DIAMOND DUST

    MDR report key: 5797959 · Received July 12, 2016

    Report

    Report Number
    MW5063434
    Event Type
    Injury
    Date Received
    July 12, 2016
    Date of Event
    June 30, 2016
    Report Date
    July 12, 2016
    Manufacturer
    SYNERGETICS CORP.
    Product Code
    HRK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    RETRACTABLE LOOP BROKE OFF INSIDE THE PATIENT'S EYE. BROKEN PIECE RETRIEVED INTRA-OPERATIVELY WITHOUT HARM TO THE PATIENT. DIAGNOSIS OR REASON FOR USE: VITRECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439599 SCRAPER MEMBRANE DIAMOND DUST 23G CURVED MEMBRANE SCRAPER HRK SYNERGETICS CORP. 338.23 F133240

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Required Intervention