BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKN ACTICOAT-7

    MDR report key: 12643545 · Received October 15, 2021

    Report

    Report Number
    8043484-2021-01871
    Event Type
    Injury
    Date Received
    October 15, 2021
    Date of Event
    October 30, 2020
    Report Date
    December 8, 2021
    Manufacturer
    SMITH & NEPHEW MEDICAL LTD.
    Product Code
    FRO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: THE COMPLAINT WAS RECEIVED AS A RESULT OF ISSUES BEING IDENTIFIED IN A LITERATURE ARTICLE. DUE TO THIS, NO SPECIFIC PRODUCT DETAILS OR BATCH/LOT NUMBERS HAVE BEEN AVAILABLE TO THE INVESTIGATION AND NO DEVICE HISTORY REVIEW WAS POSSIBLE. A COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE PRODUCT FAMILY AND EVENT DESCRIPTION, THERE HAVE BEEN FURTHER INSTANCES IN THE PAST THREE YEARS. ACCORDING TO THE ARTICLE, THE DEVICES WERE BEING USED IN PATIENT TREATMENT. THE DEVICES USED FOR TREATMENT HAVE NOT BEEN RETURNED TO SMITH AND NEPHEW FOR ANALYSIS. WE HAVE THEREFORE NOT BEEN ABLE TO CONFIRM A RELATIONSHIP BETWEEN THE EVENT AND THE DEVICE OR IDENTIFY A DEFINITIVE ROOT CAUSE. NO RELEVANT SUPPORTING CLINICAL INFORMATION HAS BEEN PROVIDED TO ASSIST WITH A CLINICAL INVESTIGATION. THE PATIENT'S CURRENT CONDITION IS UNKNOWN AND THE PATIENT IMPACT BEYOND THE REPORTED EVENTS COULD NOT BE DETERMINED BASED ON THE LIMITED INFORMATION PROVIDED. THEREFORE, BASED ON INSUFFICIENT INFORMATION, A THOROUGH CLINICAL ASSESSMENT CANNOT BE PERFORMED AT THIS TIME. SHOULD ANY ADDITIONAL CLINICAL INFORMATION BE PROVIDED THIS COMPLAINT WILL BE RE-EVALUATED. THE MEDICAL REVIEW COULD NOT ESTABLISH A LINK BETWEEN THE PRODUCT AND HARM WITHIN THIS COMPLAINT. USERS OF THE DEVICE ARE ADVISED TO CONSULT THE INSTRUCTIONS FOR USE, TO PREVENT FUTURE OCCURRENCES OF THE REPORTED ISSUE. THIS GUIDE PROVIDES COMPREHENSIVE INSTRUCTIONS OF THE OPERATION, USE AND LIMITATIONS OF THE DEVICE, INCLUDING ADVICE ON APPLICATION AND REMOVAL OF DRESSINGS. THIS INVESTIGATION HAS NOW BEEN CLOSED. NO FURTHER ACTIONS BY SMITH AND NEPHEW ARE DEEMED NECESSARY AT THIS STAGE. WE WILL CONTINUE TO MONITOR FOR ANY ADVERSE TRENDS RELATING TO ALL PRODUCT RANGES.

    Additional Manufacturer Narrative · 1

    (B)(4). NEDOMANSKY, J., ORAMARY, A., NICKL, S., FUCHS, G., RADTKE, C., HASLIK, W., & FOCHTMANN-FRANA, A. (2021). TREATMENT OF PARTIAL THICKNESS BURNS OF THE FACE WITH ACTICOAT7¿. WIENER KLINISCHE WOCHENSCHRIFT, 133(5), 202-208. DOI: 10.1007/S00508-020-01757-Z. POSTAL CODE (B)(6).

    Description of Event or Problem · 1

    ON THE LITERATURE ARTICLE NAMED "TREATMENT OF PARTIAL THICKNESS BURNS OF THE FACE WITH ACTICOAT7 - A RETROSPECTIVE SINGLE CENTER STUDY", THE AUTHORS OF THE STUDY REPORTED THAT, 4 PATIENTS FROM THE DEEP PARTIAL THICKNESS BURNS GROUP TREATED WITH ACTICOAT7 REQUIRED SECONDARY SCAR REVISION DUE TO FUNCTIONAL AREAS IMPAIRED BY HYPERTROPHIC SCARRING. ONE PATIENT HAD THE HYPERTROPHIC SCARRING ON THE EYELID AND MOUTH AREA, AND 3 PATIENTS HAD HYPERTROPHIC SCARRING ON THE MOUTH AREA. ADDITIONAL DETAILS ABOUT THE SURGERY ARE UNKNOWN. PATIENTS OUTCOME IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1536724 UNKN ACTICOAT-7 DRESSING, WOUND, DRUG FRO SMITH & NEPHEW MEDICAL LTD. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other