BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTICOAT FLEX 7 5X5

    MDR report key: 2210747 · Received August 12, 2011

    Report

    Report Number
    3006760724-2011-00013
    Event Type
    Injury
    Date Received
    August 12, 2011
    Date of Event
    March 11, 2011
    Report Date
    March 11, 2011
    Manufacturer
    SMITH & NEPHEW WOUND MANAGEMENT
    Product Code
    FRO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION INTO THIS COMPLAINT WAS INCONCLUSIVE. NO SAMPLES OR LOT INFORMATION WAS PROVIDED WHICH LIMITED THE INVESTIGATION. THE IFU PROVIDED WITH FLEX PRODUCTS STATES THAT A SECONDARY DRESSING SHOULD BE APPLIED TO MAINTAIN A MOIST ENVIRONMENT AND/OR ABSORB FLUID IN A HIGHLY EXUDING WOUND. THE FLEX DRESSINGS ARE NOT INTENDED TO ABSORB MOISTURE BUT RATHER TO ALLOW FLUIDS TO PASS THROUGH THE BARRIER WITHOUT IMPAIRMENT. IN CASES WHERE THE WOUND ENVIRONMENT IS NOT KEPT MOIST, THE DRESSING WILL GET STUCK TO THE WOUND. THIS IS LIKELY THE CAUSE OF THE STUCK SKIN THOUGH WITHOUT FURTHER DETAILS REGARDING SECONDARY DRESSING USE, IT CANNOT BE CONCLUSIVELY DETERMINED AS THE ROOT CAUSE. IF THIS OCCURS, THE DRESSING SHOULD BE MOISTENED TO AID IN REMOVAL & AVOID DISRUPTION OF THE WOUND BED. DUE TO A SLIGHT INCREASE IN REPORTS OF THIS NATURE, THE IFU WAS UPDATED TO CLARIFY THE NEED TO MAINTAIN A MOIST ENVIRONMENT AND ABSORB HEAVY EXUDATES WITH A SECONDARY DRESSING. THE REPS HAVE BEEN INFORMED THAT ADDITIONAL TRAINING MAY BE NECESSARY FOR NEW/CURRENT CUSTOMERS USING THE FLEX LINE. A (B)(4) REVIEW WAS PERFORMED. THE RISK IDENTIFIED FOR DRESSINGS USED ON DRY/ NON-EXUDING WOUNDS WHICH ARE NOT MOISTENED IS DRESSING ADHERENCE TO THE WOUND AND CAUSING PAIN/ TRAUMA UPON REMOVAL. (B)(4). NO FURTHER CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME BUT WE WILL CONTINUE TO MONITOR FOR TRENDS. SHOULD THE IDENTIFIED ACTIONS TAKEN BE DEEMED INEFFECTIVE, FURTHER INVESTIGATION WILL BE PERFORMED.

    Description of Event or Problem · 1

    EVENT OCCURRED AT (B)(6). ADVERSE INCIDENT USED FLEX ON AN (B)(6) PATIENT, WHEN THE DRESSING WAS REMOVED IT CAUSED TRAUMA TO THE WOUND AND RESULTED IN A LOT OF BLEEDING. BECAUSE OF THIS THE CHILD NEEDED TO HAVE A BLOOD TRANSFUSION - NOT SOMETHING THEY WOULD NORMALLY DO WITH A CHILD SO YOUNG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTICOAT FLEX 7 5X5 DRESSING, WOUND, DRUG FRO SMITH & NEPHEW WOUND MANAGEMENT 66800395

    Patients

    Seq Age Sex Outcome Treatment
    1 18 MO Other