BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELIATECT(TM) POST-OP DRESSING WITH CHG

    MDR report key: 7445080 · Received April 19, 2018

    Report

    Report Number
    3003764829-2018-00004
    Event Type
    Injury
    Date Received
    April 19, 2018
    Date of Event
    November 14, 2017
    Report Date
    April 19, 2018
    Manufacturer
    AVERY DENNISON CORPORATION
    Product Code
    FRO
    PMA / PMN Number
    K163529
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A CLINICIAN REPORTED THAT THE DEVICE ADHERED TO THE SKIN AND REMOVED THE DERMABOND. IT WAS ALSO NOTED THAT THE DRESSING STUCK TO THE SUTURE TAILS AT THE END OF THE INCISION PULLING UP THE SCABS AND CAUSING THE INCISION TO BLEED. NO MEDICAL INTERVENTION WAS REPORTED. THE PART NUMBER AND LOT NUMBER WERE NOT PROVIDED FOR THE COMPLAINT. THEREFORE, BOTH SIZES OF THE POST-OP DRESSINGS WERE EVALUATED AS PART OF THE COMPLAINT INVESTIGATION. SINCE THIS CONSERVATIVE APPROACH WAS EMPLOYED, ALL PRODUCTION LOTS SHIPPED WITHIN THE COMPLAINT TIME FRAME WERE TREATED AS SUSPECT AND EVALUATED. BASED ON THE NATURE OF THE INCIDENT, RETAIN SAMPLES WERE TESTED FOR ADHESION AND RELATED PERFORMANCE CHARACTERISTICS. ALL THE RESULTS WERE FOUND TO BE WITHIN SPECIFICATIONS. IN ADDITION, AVERY DENNISON CONDUCTED A DEVICE HISTORY RECORD REVIEW FOR ALL SUSPECTED LOTS. THE REVIEW CONFIRMED THAT THE PERFORMANCE CHARACTERISTICS WERE WITHIN SPECIFICATION AT THE TIME OF PRODUCT RELEASE. IT IS ALSO IMPORTANT TO NOTE THAT THE IFU FOR THE CONCOMITANT SKIN CLOSURE DEVICE STATES THAT A DRY WOUND DRESSING, SUCH A GAUZE, MAY BE APPLIED AFTER THE ADHESIVE HAS BEEN COMPLETELY POLYMERIZED. THE RELIATECT(TM) IS NOT CONSIDERED A DRY WOUND DRESSING.

    Description of Event or Problem · 1

    A CLINICIAN REPORTED THAT THE DRESSING REMOVED THE DERMABOND ON THE INCISION SITE AND PULLED AT THE SCABS CAUSING THE INCISION TO BLEED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287497 RELIATECT(TM) POST-OP DRESSING WITH CHG DRESSING, WOUND, DRUG FRO AVERY DENNISON CORPORATION MED 9903MS OR MED 9904MS NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other