BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAPTIC TOUCH¿ NON-ADHERING SILICONE DRESSING

    MDR report key: 8647538 · Received May 28, 2019

    Report

    Report Number
    3007663067-2019-00005
    Event Type
    Injury
    Date Received
    May 28, 2019
    Report Date
    May 28, 2019
    Manufacturer
    SYSTAGENIX WOUND MANAGEMENT MANUFACTURING LTD
    Product Code
    NAD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: THE DATE OF THE EVENT IS UNKNOWN. THE EVENT WAS REPORTED TO KCI ON 29-APR-2019. DEVICE EVALUATED BY MFR: DEVICE NOT RETURNED/ NO IDENTIFIER KNOWN. BASED ON THE INFORMATION PROVIDED, IT CANNOT BE DETERMINED THAT THE PARTIAL GRAFT FAILURE IS RELATED TO THE ADAPTIC TOUCH¿ NON-ADHERING SILICONE DRESSING. IT WAS UNKNOWN HOW MUCH TIME ELAPSED FROM THE GLUE APPLICATION TO THE GRAFT PLACEMENT. THIS REPORT IS BEING FILED DUE TO POSSIBLE USER ERROR. NO ADDITIONAL INFORMATION IS AVAILABLE DUE TO THE LIMITED INFORMATION PROVIDED. DEVICE LABELING, AVAILABLE IN PRINT AND ONLINE STATES: INDICATIONS: ADAPTIC TOUCH¿ NON-ADHERING SILICONE DRESSING IS DESIGNED AS A PRIMARY WOUND CONTACT LAYER FOR USE IN THE MANAGEMENT OF DRY TO HEAVILY EXUDATING, PARTIAL AND FULL-THICKNESS CHRONIC WOUNDS INCLUDING VENOUS ULCERS, DECUBITUS (PRESSURE) ULCERS AND DIABETIC ULCERS, AND FOR TRAUMATIC AND SURGICAL WOUNDS, DONOR SITES AND 1ST AND 2ND DEGREE BURNS. CONTRAINDICATIONS: ADAPTIC TOUCH¿ NON-ADHERING SILICONE DRESSING IS NOT INDICATED FOR: SURGICAL IMPLANTATION. DRESSING APPLICATION: COVER WITH AN APPROPRIATE ABSORBENT SECONDARY DRESSING, E.G. TIELLE HYDROPOLYMER DRESSING. ADAPTIC TOUCH¿ MAY ALSO BE SUITABLE FOR USE, UNDER MEDICAL SUPERVISION, WITH NEGATIVE PRESSURE WOUND THERAPY (NPWT) FOR THE PROTECTION OF FRAGILE WOUND STRUCTURES.

    Description of Event or Problem · 1

    ON 29-APR-2019, THE FOLLOWING INFORMATION WAS REPORTED TO KCI: THE PATIENT HAD A GRAFT PLACED USING GLUE INSTEAD OF SUTURES OR STAPLED IN PLACE. ADAPTIC TOUCH¿ NON-ADHERING SILICONE DRESSING WAS APPLIED WITH V.A.C.® THERAPY. UPON PERFORMING A DRESSING CHANGE, THE ADAPTIC TOUCH¿ DRESSING ALLEGEDLY ADHERED TO THE GRAFT. THE CENTER OF THE GRAFT WAS INCORPORATED AND ONLY THE EDGES OF THE GRAFT WERE ADHERED TO THE DRESSING. IT WAS UNKNOWN HOW MUCH TIME ELAPSED FROM THE GLUE APPLICATION TO THE GRAFT PLACEMENT. ON 28-MAY-2019, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE NURSE: THE GRAFT WAS VIABLE WITH SMALL AREAS THAT REQUIRED RE-SUTURING. THE NURSE NOTED A LOT NUMBER WAS UNAVAILABLE AS THE PRODUCT WAS DISCARDED. THE ADAPTIC TOUCH¿ DRESSING LOT NUMBER WAS NOT PROVIDED, THEREFORE, A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED. THE ADAPTIC TOUCH¿ DRESSING WAS CONFIRMED DISCARDED SO NO PRODUCT IS AVAILABLE FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439162 ADAPTIC TOUCH¿ NON-ADHERING SILICONE DRESSING NAD NAD SYSTAGENIX WOUND MANAGEMENT MANUFACTURING LTD ADPTCH ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Required Intervention