BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BICONTACT PLASMAPORE 12/14 SIZE 17MM

    MDR report key: 2565537 · Received April 27, 2012

    Report

    Report Number
    3005673311-2012-00018
    Event Type
    Malfunction
    Date Received
    April 27, 2012
    Date of Event
    October 1, 2011
    Report Date
    March 28, 2012
    Manufacturer
    AESCULAP AG & CO. KG
    Product Code
    LWJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS ITEM IS NOT DISTRIBUTED IN THE UNITED STATES; HOWEVER, AESCULAP IMPLANT SYSTEMS DOES DISTRIBUTE SIMILARLY PACKAGED ITEMS. NO ADVERSE EVENTS HAVE BEEN REPORTED BY U.S CUSTOMERS DUE TO SIMILAR PACKAGING INCONSISTENCIES. PRODUCT EVAL: WHEN OPENING THE PACKAGING, WE HAVE FOUND THAT THE DISTAL END OF THE PACKAGING HAS A DAMAGES PRIMARY AND SECONDARY STERILE PACKAGING AT A WIDTH OF APPROX 2 CM. THE INSIDE THE PRIMARY PACKAGING HAS SCRUFF MARKS THAT INDICATE THAT THE PRODUCT MOVED INSIDE THE PACKAGING. THE PRODUCT HISTORY WAS PREVIEWED. THE DOCUMENTATION DOES NOT SHOW ANY DEVIATIONS. NO FURTHER COMPLAINT OF PRODUCTS OF THIS BATCH HAVE BEEN REPORTED. THEREFORE A SYSTEMATIC ERROR CAN BE EXCLUDED. DUE TO THE DAMAGES WE ASSUME THAT THE BREAKAGE OF PACKAGING WAS CAUSED DURING TRANSPORTATION. THE PRODUCT WAS MFG IN JUNE 2009. WE DO NOT HAVE ANY INFO ABOUT HOW OFTEN THE PRODUCT WAS TRANSPORTED. IN THE MEANTIME THE PACKAGING PROCESS WAS VALIDATED TO ENSURE A FIRMER FIXATION OF THE SHAFT INSIDE THE PACKAGING. THE PRODUCT WAS MFG PRIOR TO THIS VALIDATION.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). ACCORDING TO CUSTOMER COMPLAINT: "THERE WERE HOLE IN THE PRIMARY PACKAGE. THE HOLE OCCURRED BY OWN PRODUCT, AFFECTING THEIR STERILITY. THAT WAS OBSERVED DURING THE PROCEDURE AND CAUSED INCONVENIENCE TO SURGERY." NO INJURY WAS REPORTED. DELAY TIME IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BICONTACT PLASMAPORE 12/14 SIZE 17MM NONE LWJ AESCULAP AG & CO. KG NK727T 51300923D

    Patients

    Seq Age Sex Outcome Treatment
    1 Other