BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAPTIC TOUCH NON-ADHERING SILICONE DRESSING

    MDR report key: 4337938 · Received December 9, 2014

    Report

    Report Number
    3007663067-2014-00004
    Event Type
    Injury
    Date Received
    December 9, 2014
    Date of Event
    September 1, 2014
    Report Date
    October 30, 2014
    Manufacturer
    SYSTAGENIX WOUND MANAGEMENT MANUFACTURING LIMITED
    Product Code
    FRO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, IT CANNOT BE DETERMINED THE BLEEDING WAS DUE TO THE REMOVAL OF ADAPTIC NON-ADHERING SILICONE DRESSING. SYSTAGENIX HAS NOT BEEN ABLE TO OBTAIN SUFFICIENT INFORMATION TO ESTABLISH A ROOT CAUSE. ADAPTIC TOUCH NON-ADHERING SILICONE DRESSING IS DESIGNED AS A PRIMARY WOUND CONTACT LAYER FOR USE IN THE MANAGEMENT OF DRY TO HEAVILY EXUDING, PARTIAL AND FULL-THICKNESS CHRONIC WOUNDS INCLUDING VENOUS ULXCERS, AND FOR TRAUMATIC AND SURGICAL WOUNDS, DONOR SITES AND 1ST AND 2ND DEGREE BURNS. IT IS ALSO SUITABLE FOR USE, UNDER MEDICAL SUPERVISION, WITH NPWT. ADAPTIC TOUCH NON-ADHERING SILICONE DRESSING IS NOT INDICATED FOR: PATIENTS WITH A KNOWN SENSITIVITY TO SILICONE OR CELLULOSE ACETATE FABRIC; SURGICAL IMPLANTATION.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE PHYSICIAN: ON (B)(6) 2014, ADAPTIC NON-ADHERING SILICONE DRESSING, IN COMBINATION WITH MILD COMPRESSION, WAS TESTED AT THE PATIENT'S AMPUTATION STUMP. ALLEGEDLY THE ADAPTIC TOUCH NON-ADHERING SILICONE DRESSING WAS "MASSIVELY CONNATED IN THE WOUND BASE AND THERE WAS HEAVY BLEEDING DURING DETACHMENT, DESPITE IRRIGATION". NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    792922 ADAPTIC TOUCH NON-ADHERING SILICONE DRESSING NONE FRO SYSTAGENIX WOUND MANAGEMENT MANUFACTURING LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1 Other