BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILVERCEL NON ADHERENT ALGINATE DRESSING

    MDR report key: 8173504 · Received December 18, 2018

    Report

    Report Number
    8044178-2018-00004
    Event Type
    Injury
    Date Received
    December 18, 2018
    Date of Event
    December 13, 2018
    Report Date
    February 12, 2019
    Manufacturer
    ADVANCED MEDICAL SOLUTIONS GROUP PLC
    Product Code
    FRO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT, 12FEB2019; FOLLOWING RECEIPT OF THE VIDEO RELATING TO A PATIENT AND DISCUSSIONS WITH THE COMPLAINTANT, ADVANCED MEDICAL SOLUTIONS ARE REPORTING THE INCIDENT AS AN ADVERSE EVENT.

    Description of Event or Problem · 0

    FOLLOW UP REPORT, 12FEB2019. ADDITIONAL INFORMATION PROVIDED BY THE COMPLAINANT INVOLVES A VIDEO RELATING TO THE REMOVAL OF THE SILVERCEL NON ADHERENT ALGINATE DRESSING FROM A WOUND AS A RESULT OF A TOE AMPUTATION. THE ETHYLENE METHYL ACRYLATE (EMA) LAYER SEPARATES FROM THE DRESSING AND ADHERES TO THE WOUND. THE HEALTHCARE PROFESSIONAL IS ABLE TO LIFT THE EMA FILM FROM THE SKIN AND REMOVE IT FROM THE WOUND AREA. THE COMPLAINANT HAS NOT PROVIDED PATIENT RELATED INFORMATION IN SUPPORT OF THE VIDEO IN TERMS OF SUBSEQUENT ACTIONS AND THE STATUS OF THE PATIENT. THE COMPLAINANT STATES THE COMPLAINT IS NOT PATIENT SPECIFIC OR LOT SPECIFIC BUT GENERAL USE OF THE PRODUCT WITH MULTIPLE PATIENTS OVER A PERIOD OF TIME.

    Additional Manufacturer Narrative · 1

    FOLLOWING RECEIPT OF THE COMPLAINT, A REVIEW OF THE ROUTINE QC TESTING OF THE INTERMEDIATES USED IN LOT W00029400 WAS PERFORMED AND ALL RESULTS, INCLUDING WET DELAMINATION, WERE WITHIN SPECIFICATION. A REVIEW OF THE BATCH RECORDS FOR LOT W00029400 AND THE INTERMEDIATES CONSUMED WITHIN THIS LOT WAS CONDUCTED AND NO ISSUES WERE IDENTIFIED THAT COULD CONTRIBUTE TO THIS DEFECT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE FILM THAT COATS NON ADHERENT FIBER LOOSE AND ADHERES TO THE WOUND. THE CUSTOMER REPORTS THE ISSUE IS NOT LOT SPECIFIC, BUT AFFECTING LONG TERM EXPERIENCE WITH MULTIPLE PATIENTS OVER A PERIOD OF TIME, SINCE THEY STARTED USING THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1016577 SILVERCEL NON ADHERENT ALGINATE DRESSING SILVERCEL NON ADHERENT ALGINATE DRESSING FRO ADVANCED MEDICAL SOLUTIONS GROUP PLC N/A W00029400

    Patients

    Seq Age Sex Outcome Treatment
    1 Other