BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BICONTACT S PLASMAPORE 12/14 SIZE 17MM

    MDR report key: 2565515 · Received April 27, 2012

    Report

    Report Number
    3005673311-2012-00016
    Event Type
    Malfunction
    Date Received
    April 27, 2012
    Date of Event
    October 24, 2011
    Report Date
    March 28, 2012
    Manufacturer
    AESCULAP AG & CO. KG
    Product Code
    JWH
    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 SYSTEM DOES DISTRIBUTE SIMILARLY PACKAGED ITEMS. NO ADVERSE EVENTS HAVE BEEN REPORTED BY US CUSTOMERS DUE TO SIMILAR PACKAGING INCONSISTENCIES. MFG FACILITY EVAL INDICATES THE SEALING SEAMS OF THE PRIMARY AND SECONDARY PACKAGING IS OPEN AT A WIDTH OF APPROX. 4 CM. WE HAVE REVIEWED THE PRODUCTION DOCUMENTATION AND NO FURTHER COMPLAINT OF PRODUCTS OF THIS BATCH HAVE BEEN REPORTED. WE ASSUME THAT THE DAMAGE WAS CAUSED DURING TRANSPORTATION. THE PRODUCT WAS MANUFACTURED IN 2009 AND THE COMPLAINT WAS REPORTED IN 2011. IT IS UNK UNDER WHICH CONDITIONS AND HOW OFTEN THE PRODUCT WAS TRANSPORTED. IN THE MEANTIME WE HAVE RE-VALIDATED THE PRODUCTION PROCESS TO ENSURE A FIRMER FIXATION OF THE PRODUCT INSIDE THE PACKAGING. THE PRODUCT WAS MANUFACTURED PRIOR TO THIS MEASURE.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). DAMAGED / PACKAGE. THERE WAS A HOLE IN THE PRIMARY PACKAGE; AFFECTING THE STERILITY. NO PT INJURY OR PROLONGING OF SURGERY WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BICONTACT S PLASMAPORE 12/14 SIZE 17MM NONE JWH AESCULAP AG & CO. KG NK517T 51570225

    Patients

    Seq Age Sex Outcome Treatment
    1 Other