BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PISTON FOR 7-9 MM BLADES

    MDR report key: 227781 · Received June 15, 1999

    Report

    Report Number
    1045254-1999-00007
    Event Type
    Injury
    Date Received
    June 15, 1999
    Date of Event
    May 11, 1999
    Report Date
    May 12, 1999
    Manufacturer
    XOMED SURGICAL PRODUCTS, INC.
    Product Code
    HNJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CORNEAL TRANSPLANT PROCEDURE USING WECK TREPHINE, PISTON AND CUTTING BLOCK RESULTED IN LEAKING AROUND THE TRANSPLANTED CORNEA. ADD'L SURGERY PERFORMED 5/11/99 TO SEAL LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PISTON FOR 7-9 MM BLADES CORNEAL PUNCH HNJ XOMED SURGICAL PRODUCTS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Required Intervention 1. TROUTMAN CORNEAL PUNCH REPLACEMENT BLOCK| (STOP'D)).| 2. TREPHINE BLADE 8.0MM (05/05/1999 TO 05/05/1999| (05/05/1999 TO 05/05/1999 (STOP'D)),