BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    L-CLIP PERM BAYONET 7 MM

    MDR report key: 3981072 · Received December 18, 2013

    Report

    Report Number
    1045834-2013-16099
    Event Type
    Malfunction
    Date Received
    December 18, 2013
    Report Date
    August 31, 2011
    Manufacturer
    PETER LAZIC GMBH
    Product Code
    HCI
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED BY (B)(4). (B)(4) IS THE IMPORTER OF THE DEVICE. IF ADDITIONAL INFO IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT. (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM THE USA STATING THAT "PACKAGE LABELED AS A 45.748 ACTUALLY CONTAINS 45.744." THE DEVICE WAS NOT BEING USED DURING SURGERY. NO INJURY OR MEDICAL INTERVENTION OCCURRED. THE DATE OF EVENT IS UNK. THERE WAS NO ADDITIONAL INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663712 L-CLIP PERM BAYONET 7 MM NONE HCI PETER LAZIC GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1