BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURAGEN PLUS ADHESION BARRIER MATRIX 3X3, 5 PACK

    MDR report key: 9240745 · Received October 25, 2019

    Report

    Report Number
    1121308-2019-00044
    Event Type
    Malfunction
    Date Received
    October 25, 2019
    Report Date
    October 3, 2019
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION
    Product Code
    GXQ
    PMA / PMN Number
    K032693
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN IF THE DEVICE WILL BE RETURNED TO THE MANUFACTURER FOR EVALUATION. THE PLANT INVESTIGATION IS IN PROGRESS AND A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION, THEREFORE THE FAILURE MODE COULD NOT BE CONFIRMED. THE DEVICE HISTORY RECORD PERFORMED ON FINISHED GOOD LOT 1140552 SHOWED NO ANOMALY DURING THE PROCESS OF THIS LOT THAT COULD BE RELATED TO THE REPORTED CONDITION. AS PART OF MANUFACTURING/PACKAGING DOCUMENTATION, SAMPLES OF PRINTED MATERIAL ARE ATTACHED TO THE DHR AND ALL SHOWED THE CORRECT EXPIRATION DATE (SAME AS REPORTED BY THE CUSTOMER: 03-2017). NO EXPIRATION DATE RELATED QUALITY EVENTS WERE GENERATED TO LOT 1140552. NO DEFECT WAS DETECTED AT INTEGRA-AÑASCO, PR FROM A MANUFACTURING/PACKAGING/SHIPPING POINT OF VIEW. ROOT CAUSE COULD NOT BE DETERMINED AT THIS TIME.

    Description of Event or Problem · 1

    A COMPLAINT ANALYST REPORTED THAT THE DP5033I DURAGEN PLUS ADHESION BARRIER MATRIX 3X3 WAS PURCHASED ON (B)(6) AND HAD AN EXPIRATION DATE OF MAR2017. THE SITUATION WAS DISCOVERED DURING TRANSFER TO THE CUSTOMER. NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    N/A

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1034014 DURAGEN PLUS ADHESION BARRIER MATRIX 3X3, 5 PACK N/A GXQ INTEGRA LIFESCIENCES CORPORATION 1140552

    Patients

    Seq Age Sex Outcome Treatment
    1