BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILVERCEL NON-ADHERENT ANTIMICROBIAL ALGINATE DRESSING

    MDR report key: 8737097 · Received June 26, 2019

    Report

    Report Number
    8044178-2019-00005
    Event Type
    Malfunction
    Date Received
    June 26, 2019
    Date of Event
    April 1, 2018
    Report Date
    September 25, 2019
    Manufacturer
    ADVANCED MEDICAL SOLUTION LTD
    Product Code
    FRO
    PMA / PMN Number
    K081363
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INSUFFICIENT INFORMATION PROVIDED AND AT THIS TIME TO CONFIRM IF PRODUCT WAS USED AS INTENDED AND CONTRIBUTED OR CAUSED THE MALFUNCTION. IF FURTHER INFORMATION BECOMES AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS A FINAL REPORT FOR (B)(4), THE INITIAL REPORT WAS SUBMITTED ON 26TH JUNE 2019. ADVANCED MEDICAL SOLUTIONS LTD. (AMS) HAS CONTACTED THE CUSTOMER REQUESTING ADDITIONAL INFORMATION, HOWEVER THE CUSTOMER CONFIRMED THAT NO FURTHER INFORMATION IS AVAILABLE, INCLUDING PRODUCT LOT NUMBERS AND PART NUMBERS. AS NO BATCH DETAILS WERE AVAILABLE FOR THIS COMPLAINT, AN INVESTIGATION INCLUDING BATCH REVIEW, SAMPLE REVIEW, ADDITIONAL TESTING FOR REVIEW OF RELEASE SPECIFICATION COULD NOT BE PERFORMED. AMS DEEM THE RISK TO THE PATIENT TO BE LOW AS PRODUCT INSTRUCTIONS FOR USE STATE 'IF THE WOUND APPEARS DRY, SATURATE THE DRESSING WITH STERILE SALINE PRIOR TO REMOVAL'. FOLLOWING A TOTAL OF 4 COMPLAINTS FROM THE SAME CUSTOMER REGARDING THE SAME ISSUE, DELAMINATION OF THE NON-ADHERENT LAYER OF THE DEVICE, AMS HAS RAISED A CAPA TO INVESTIGATE THE ISSUE. INVESTIGATIONS INTO THE ROOT CAUSE OF THE ISSUE ARE ON GOING, MANUFACTURING EQUIPMENT, MATERIALS ARE BEING INVESTIGATED ALONG WITH DATA ANALYSIS FROM PREVIOUS BATCHES OF THE DEVICE. IN ACCORDANCE WITH AMS PROCEDURES, QUALITY CONTROL TESTING IS PERFORMED FOR EACH MANUFACTURED BATCH OF THE DEVICE, PRODUCT WHICH HIGHLIGHT LAMINATION FAILURES ARE FURTHER INVESTIGATED AND THE AFFECTED PRODUCT IS QUARANTINED AND DISPOSED OF. AS THE CUSTOMER IS NOT ABLE TO PROVIDE FURTHER INFORMATION REGARDING THE COMPLAINT AND AMS ARE INVESTIGATING THE ROOT CAUSE AND APPROPRIATE CORRECTIVE MEASURES, AMS CONSIDER THIS TO BE FINAL REPORT FOR THIS INCIDENT.

    Description of Event or Problem · 1

    THE NON-ADHERENT LAYER OF SILVERCEL NA DELAMINATED AND WAS LEFT IN THE WOUND UPON REMOVAL. NO PATIENT HARM OR ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    FOLLOWING INITIAL COMPLAINT DETAILS RECEIVED FROM THE CUSTOMER, THE CUSTOMER CONFIRMED THAT NO FURTHER INFORMATION IS AVAILABLE, INCLUDING PRODUCT LOT NUMBERS AND/OR PART NUMBERS. CUSTOMER HAS NOT REPORTED DETAILS OF A PATIENT BEING HARMED OR OF A CLINICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531083 SILVERCEL NON-ADHERENT ANTIMICROBIAL ALGINATE DRESSING EXUDATE-ABSORBENT DRESSING, HYDROPHILIC GEL, ANTIMICROBIAL, FRO ADVANCED MEDICAL SOLUTION LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 Other