BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADAPTIC TOUCH NON-ADHERING SILICONE DRESSING

    MDR report key: 3240825 · Received July 17, 2013

    Report

    Report Number
    3007663067-2013-00001
    Event Type
    Other
    Date Received
    July 17, 2013
    Date of Event
    June 6, 2013
    Report Date
    July 3, 2013
    Manufacturer
    SYSTAGENIX WOUND MANAGEMENT MANUFACTURING LIMITED
    Product Code
    FRO
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION CODE: REMOVAL DIFFICULTIES. FROM (B)(6) 2012, UNTIL THE SPRING OF 2013, DR (B)(6) AT (B)(6) WAS TESTING ADAPTIC TOUCH (WITHOUT ANY PARTICIPATION OR KNOWLEDGE OF A USE OF WOUND DRESSINGS USED TO COVER DONOR SITES IN SEVERELY BURNED PTS, THE HOSPITAL CHANGED TO USING ADAPTIC TOUCH WITH A SECONDARY DRESSING OF MULL GAUZE. ADAPTIC TOUCH WAS LEFT ON THE WOUND FOR A MINIMUM OF 7 DAYS, VERY OFTEN THOUGH FOR 10-14 DAYS. THE MULL GAUZE WAS CHANGED MORE OFTEN. IN A NUMBER OF CASES WITH REMOVAL OF THE ADAPTIC TOUCH, FRESH GROWN TISSUE WAS DISLODGED AND THE PTS COMPLAINED ABOUT PAIN. WITH ONE PT THE ADAPTIC TOUCH HAD TO BE REMOVED SURGICALLY. LOT NUMBERS OF PRODUCT USED DURING THE PERIOD (B)(6) 2012 TO THE DATE OF THE EVENT (B)(6) 2013, WERE LOT 1243 (EXP 2014/08), LOT 1303 (EXP 2014/12), LOT 1201 (EXP 2013/12) AND LOT 1246 (EXP 2014/10). IT IS NOT KNOWN WHICH LOT WAS RELATED TO THE ADVERSE EVENT.

    Description of Event or Problem · 1

    KNITTED CELLULOSE ACETATE SILICONE NON-ADHERENT DRESSING APPLIED TO BASE OF WOUND. THE DRESSING WAS USED TO COVER DONOR SITE IN SEVERELY BURNED PT. KNITTED CELLULOSE ACETATE SILICONE NON-ADHERENT DRESSING WAS LEFT ON THE WOUND FOR BETWEEN 7 DAYS AND 14 DAYS WITH A SECONDARY DRESSING OF MULL GAUZE. THE KNITTED CELLULOSE ACETATE SILICONE NON-ADHERENT DRESSING ADHERED TO THE FRESH TISSUE AND HAD TO BE REMOVED SURGICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331851 ADAPTIC TOUCH NON-ADHERING SILICONE DRESSING WOUND-NONADHERENT DRESSING, PERMEABLE FRO SYSTAGENIX WOUND MANAGEMENT MANUFACTURING LIMITED UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other