BEUDAMED
    FDA Adverse Event Death Summary report: N

    AUTOLOCK/LOCK FLANGE 2 PC DURAHESIVE FLEXIBLE

    MDR report key: 3674915 · Received February 28, 2014

    Report

    Report Number
    9618003-2014-00022
    Event Type
    Death
    Date Received
    February 28, 2014
    Date of Event
    February 5, 2014
    Report Date
    February 5, 2014
    Manufacturer
    CONVATEC INC.
    Product Code
    EXE
    PMA / PMN Number
    K840166
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A FINAL QUALITY EVALUATION WAS PERFORMED ON 07/16/2014. BASED ON THE EVALUATION OF MATERIALS AND PROCESSES, THERE IS NO CHANGE TO THE PRODUCTS THAT CAN INDICATE ASSIGNABLE SITUATIONS THAT WOULD ACCOUNT FOR THE ADVERSE EVENTS REPORTED. THE BATCH RECORD REVIEW OF AFFECTED LOTS WAS NOT CONDUCTED BECAUSE THERE IS NO QUALITY DATA RECORD THAT CAN PROVIDE PRODUCT USABILITY TESTING. TO THE EXTENT THAT THE DATA CAN BE EVALUATED WITHOUT HAVING ANY PRODUCT SAMPLES RETURNED FOR EVALUATION, A SPECIFIC CORRECTIVE ACTION IS NOT REQUIRED. THE RISK REVIEW MEETING, FOR THIS INVESTIGATION AND THE EVALUATION OF THE CALCULATED PROBABILITIES, WAS CONDUCTED. THE CONCLUSION DERIVED AT THIS MEETING WAS THAT THE TREND WAS NOT SIGNIFICANT AND SHOULD BE CONTINUED TO BE TRACKED AND MONITORED AGAINST A THRESHOLD OR BASELINE. KIN RELATED FIELD FEEDBACK AND/OR COMPLAINTS INFO WILL CONTINUE TO BE TRACKED AND EVALUATED ACCORDING TO CONVATEC PROCEDURES. A LOT NUMBER COULD NOT BE OBTAINED THEREFORE A REVIEW OF THE BATCH RECORD DATA COULD NOT BE PERFORMED WITHOUT A LOT NUMBER. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AN ADDITIONAL FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFO REGARDING THE SEVERITY OF THE ALLERGIC REACTION FROM THE END USERS WIFE, PRIOR TO THE END USERS DEATH, HOWEVER, NO ADDITIONAL INFO WAS ABLE TO BE OBTAINED. BASED UPON THE INFO OBTAINED AT THIS TIME, IT IS DEEMED IMPROBABLE THAT AN ALLERGIC REACTION TO THE TAPE BORDER OF AN OSTOMY PRODUCT WOULD HAVE ANY CORRELATION WITH THE PTS' DEATH. NO ADDITIONAL PT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFO BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. A RETURN SAMPLE FOR EVALUATION IS NOT EXPECTED. NOTE: THE ACTUAL DATE OF EVENT IS UNKNOWN, SO THE DATE USED WAS THE DATE CONVATEC BECAME AWARE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN END USER EXPERIENCED AN ALLERGIC REACTION TO THE TAPE BORDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124054 AUTOLOCK/LOCK FLANGE 2 PC DURAHESIVE FLEXIBLE PROTECTOR, OSTOMY EXE CONVATEC INC. 401306 1E01608

    Patients

    Seq Age Sex Outcome Treatment
    1 Death