BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKN ACTICOAT FLEX 7

    MDR report key: 13181722 · Received January 6, 2022

    Report

    Report Number
    8043484-2022-00020
    Event Type
    Injury
    Date Received
    January 6, 2022
    Date of Event
    December 17, 2021
    Report Date
    April 15, 2022
    Manufacturer
    SMITH & NEPHEW MEDICAL LTD.
    Product Code
    MGP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE: (B)(4).

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT, DURING TREATMENT, THE PATIENT HAS HAD A REACTION TO ACTICOAT FLEX 7 WITHIN THE FIRST 20 MINUTES OF USE. THE PATIENT WAS ALSO USING OCTENILIN WOUND IRRIGATION SOLUTION AND UCS CLOTH. THE DEVICE WAS USED FOR TREATMENT AND WAS NOT RETURNED FOR ANALYSIS. WE HAVE NOT BEEN ABLE TO CONFIRM A RELATIONSHIP BETWEEN THE EVENT AND THE DEVICE OR IDENTIFY A DEFINITIVE ROOT CAUSE. AS NO LOT NUMBER WAS PROVIDED IT WAS NOT POSSIBLE TO CARRY OUT A DEVICE HISTORY REVIEW A COMPLAINT HISTORY REVIEW REVEALED NO SIMILAR INSTANCES IN THE LAST THREE YEARS. REVIEW OF THE RISK FILES FOUND THE REPORTED ISSUE TO BE MITIGATED TO THE LOWEST POSSIBLE LEVEL WITH NO UPDATES REQUIRED AT THIS TIME. A CLINICAL REVIEW CONCLUDED THAT THE INFORMATION PROVIDED IS INSUFFICIENT TO DETERMINE WHETHER THE PATIENT¿S SYMPTOMS, SIGNS OR OUTCOME ARE DUE TO AN UNKNOWN ALLERGY TO SILVER, A PRE-EXISTING OR CONCURRENT MEDICAL OR SURGICAL CONDITION OR PROCEDURE, OR TO AN ADVERSE REACTION TO OR EXPERIENCE WITH THE DEVICE, ONE OR MORE OF ITS COMPONENTS, OR ITS INTENDED THERAPEUTIC ACTION. THEREFORE, THE IMPACT TO THE PATIENT BEYOND THAT WHICH HAS ALREADY BEEN REPORTED CANNOT BE CONFIRMED NOR CONCLUDED. PROBABLE ROOT CAUSE IS AN ALLERGIC REACTION BY THE PATIENT TO ONE OR MORE OF THE COMPONENTS OF THE DRESSING OR TO THE OTHER PRODUCTS USED DURING TREATMENT. THE USERS OF THE REPORTED PRODUCT ARE ADVISED TO CONSULT THE IFU, TO PREVENT FUTURE OCCURRENCES OF THE REPORTED ISSUE. THIS GUIDE PROVIDES COMPREHENSIVE INSTRUCTIONS OF THE OPERATION, USE AND LIMITATIONS OF THE DEVICE. THIS INVESTIGATION IS NOW COMPLETE, WITH NO CORRECTIVE ACTIONS REQUIRED. NO FURTHER ACTIONS BY SMITH AND NEPHEW ARE DEEMED NECESSARY AT THIS STAGE. HOWEVER, WE WILL CONTINUE TO MONITOR FOR ANY ADVERSE TRENDS RELATING TO THIS PRODUCT RANGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING TREATMENT, THE PATIENT HAS HAD A REACTION TO ACTICOAT FLEX 7 WITHIN THE FIRST 20 MINUTES OF USE. THE PATIENT WAS ALSO USING OCTENILIN WOUND IRRIGATION SOLUTION AND UCS CLOTH. THE PATIENT REQUIRED 999 CALL AND ANAPHYLAXIS MEDICATION AFTER APPLICATION. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING TREATMENT, THE PATIENT HAS HAD A REACTION TO ACTICOAT FLEX 7 WITHIN THE FIRST 20 MINUTES OF USE. THE PATIENT WAS ALSO USING OCTENILIN WOUND IRRIGATION SOLUTION AND UCS CLOTH. THE PATIENT REQUIRED 999 CALL AND ANAPHYLAXIS MEDICATION AFTER APPLICATION. THE NURSE STATED THAT THE PATIENT IS NON-COMPLIANT AND IS NOT ELEVATING THE LEGS AS REQUESTED. PATIENT IS CURRENTLY AWAITING A VASCULAR DOPPLER ON THE RIGHT LEG THAT SHOWS PERIPHERAL VASCULAR DISEASE (PVD). THE PATIENT REMAINS ON DAILY DRESSINGS. NO FURTHER COMPLICATIONS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING TREATMENT, THE PATIENT HAS HAD A REACTION TO ACTICOAT FLEX 7 WITHIN THE FIRST 20 MINUTES OF USE. THE PATIENT WAS ALSO USING OCTENILIN WOUND IRRIGATION SOLUTION AND UCS CLOTH. THE PATIENT REQUIRED 999 CALL AND ANAPHYLAXIS MEDICATION AFTER APPLICATION. THE PATIENT IS NOT ELEVATING THE LEGS AS REQUESTED AND IS AWAITING A VASC TEST RESULT. DOPPLER TO THE RIGHT LEG SHOWS PVD. THE PATIENT REMAINS ON DAILY DRESSINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2516533 UNKN ACTICOAT FLEX 7 DRESSING, WOUND AND BURN, OCCLUSIVE MGP SMITH & NEPHEW MEDICAL LTD. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Female