BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1049092-2019-00135

    MDR report key: 8320147 · Received February 8, 2019

    Report

    Report Number
    1049092-2019-00135
    Event Type
    Malfunction
    Date Received
    February 8, 2019
    Manufacturer
    CONVATEC INC
    Product Code
    NAC
    PMA / PMN Number
    EXEMPT
    Report Source
    Manufacturer report
    Reporter Location
    MT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BRAND NME: AQUACEL/ AQUACEL AG SURGICAL COVER DRESSING. COMMON DEVICE NAME: DRESSING, WOUND, HYDROPHILIC. BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. NO LOT NUMBER IS AVAILABLE. A DETAILED INVESTIGATION OR BATCH REVIEW CANNOT BE CONDUCTED. THEREFORE, THIS EVALUATION WILL BE CLOSED. THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET PRODUCT MONITORING REVIEW PROCESS. ADDITIONAL INFORMATION HAS BEEN REQUESTED, HOWEVER TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. THE LOT NUMBER WAS NOT PROVIDED. THEREFORE, WE ARE UNABLE TO DETERMINE THE SPECIFIC MANUFACTURING SITE. TWO (2) POTENTIAL MANUFACTURING SITE NUMBERS ARE LISTED BELOW. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE DRESSING WAS DIFFICULT TO REMOVE AFTER BEING IN PLACE 3-5 DAYS POST OPERATION FOR A TOTAL KNEE REPLACEMENT. THE DRESSING WAS REMOVED USING ALCOHOL AND GAUZE. IT WAS FURTHER REPORTED THAT THE ADHESIVE FELT STRONGER AND MORE AGGRESSIVE RESULTING IN PAIN FOR THE PATIENT. THE PATIENT¿S INCISION IS CLOSED WITH STAPLES AND NO INJECTIONS OR SURGICAL GLUES WERE USED PRIOR TO CLOSURE OF THE SURGICAL WOUND. THEY INFORMED THAT THE DRESSING IS NOT WARMED PRIOR TO APPLICATION, NOR IS IT STRETCHED OR APPLIED UNDER TENSION. NO HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115965 NAC CONVATEC INC WOUND CARE-UNKNOWN SURGICAL COVER DRESSI

    Patients

    Seq Age Sex Outcome Treatment
    1 56