BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRA-FIT PK SYSTEM

    MDR report key: 1623510 · Received August 27, 2009

    Report

    Report Number
    2522801-2009-00021
    Event Type
    Malfunction
    Date Received
    August 27, 2009
    Date of Event
    July 21, 2009
    Report Date
    August 18, 2009
    Manufacturer
    NETWORK MEDICAL
    Product Code
    HRH
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATE OF EVENT IS ESTIMATED. THREE (3) OTHER ULTRA-FIT PK SYSTEM PRODUCTS WERE ALSO REPORTED. THE PRODUCT INFO IS AS FOLLOWS: MODEL / CATALOG #: 11840-775; LOT #: 081442; EXP DATE: 09/30/2011. MODEL / CATALOG #: 11840-800; LOT #: 081916; EXP DATE: 11/30/2011. MODEL / CATALOG #: 11840-800; LOT #: 081577; EXP DATE: 10/31/2011. (B)(4). A 11840-775, ULTRA-FIT PK SYSTEM, .775MM VACUUM TREPHINE. A 11840-800, ULTRA-FIT PK SYSTEM, .800MM VACUUM TREPHINE.

    Description of Event or Problem · 1

    THE DATE OF EVENT IS ESTIMATED. THE DOCTOR REPORTED THAT DURING AN OPHTHALMIC PROCEDURE, EXTRA ANESTHESIA TIME WAS REQUIRED DUE TO DEFECTIVE TREPHINE PRODUCTS. THE PROCEDURE WAS DELAYED SO THAT REPLACEMENT PRODUCTS COULD BE LOCATED. POTENTIAL SAFETY ISSUES COULD ARISE FROM ADDITIONAL TIME UNDER GENERAL ANESTHESIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRA-FIT PK SYSTEM CORONET VACUUM TREPHINE HRH NETWORK MEDICAL 11840-775 081703

    Patients

    Seq Age Sex Outcome Treatment
    1 NONE MADE AVAILABLE