BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLIP, IMPLANTABLE

    MDR report key: 2963865 · Received February 15, 2013

    Report

    Report Number
    3005075853-2013-00656
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    December 18, 2012
    Report Date
    January 21, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K050344
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. ADDITIONAL INFORMATION: MULTIPLE REQUESTS FOR RETURN OF DEVICE HAVE BEEN MADE BUT NO DEVICE HAS BEEN RETURNED.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED BY USER FACILITY MEDWATCH# 2302300000-2012-8038.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69126 CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA J4CF4H

    Patients

    Seq Age Sex Outcome Treatment
    1