BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KALTOSTAT® ALGINATE WOUND DRESSING

    MDR report key: 6201662 · Received December 22, 2016

    Report

    Report Number
    1000317571-2016-00113
    Event Type
    Malfunction
    Date Received
    December 22, 2016
    Date of Event
    December 1, 2016
    Report Date
    December 1, 2016
    Manufacturer
    CONVATEC LIMITED
    Product Code
    NAC
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: (MANUFACTURING DATE). NO PHYSICAL SAMPLE HAS BEEN RECEIVED. BATCH RECORDS HAVE BEEN REVIEWED; ALL REQUIRED SPECIFICATION WAS MET AND DOCUMENTED WITHIN THE BATCH RECORDS. THERE WERE NO DISCREPANCIES NOTED IN THE BATCH RECORD RELATED TO THE REPORTED COMPLAINT ISSUE. PREVENTIVE MAINTENANCE (PM) WERE REVIEWED AND ALL WERE COMPLETED TO SCHEDULE. MACHINE LOGS WERE REVIEWED AND THERE WAS NO ISSUE RELATING TO THE COMPLAINT. THE PRODUCTION MONITORING PROGRAM DID NOT LIST ANY ISSUES FOR THIS BATCH RELATING TO THE COMPLAINT. A NON-CONFORMANCE (NC) WAS OPENED PREVIOUSLY FOR THIS ISSUE ON THIS MANUFACTURING LINE. A BATCH RECORD REVIEW INDICATES NO DISCREPANCIES; ALL REQUIRED SPECIFICATION WAS MET AND DOCUMENTED WITHIN THE BATCH RECORDS. A PHOTOGRAPH WAS RECEIVED FOR THIS CASE, A SPECK WAS VISIBLE BUT THE IDENTITY AND ORIGIN OF THE ORIGIN OF THE 'CONTAMINANT' COULD NOT BE DETERMINED. THE PREVIOUS NC ASSOCIATED WITH THIS COMPLAINT WHICH IS CLOSED. NO ADDITIONAL INVESTIGATION IS REQUIRED. THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET MONITORING REVIEW PROCESS. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. REPORTED TO THE FDA ON FEBRUARY 10, 2017. (B)(4).

    Additional Manufacturer Narrative · 1

    UPDATED DATA: MANUFACTURING DATE (01/2016). BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN REQUESTED BUT NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOREIGN MATTER WAS PRESENT IN THE STERILE PACKAGE. NO FURTHER DETAILS HAVE BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    849940 KALTOSTAT® ALGINATE WOUND DRESSING DRESSING,WOUND,HYDROPHILIC NAC CONVATEC LIMITED 168215 6A00544

    Patients

    Seq Age Sex Outcome Treatment
    1