BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AQUACEL SURGICAL COVER DRESSING

    MDR report key: 1962709 · Received January 11, 2011

    Report

    Report Number
    2243969-2011-00004
    Event Type
    Injury
    Date Received
    January 11, 2011
    Date of Event
    December 3, 2010
    Report Date
    December 16, 2010
    Manufacturer
    CONVATEC
    Product Code
    FRO
    PMA / PMN Number
    K091034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED TO THE FDA ON (B)(4) 2011.

    Description of Event or Problem · 1

    REPORTED BY THE COMPLAINANT AS FOLLOWS: CONSULTANT ORTHOPAEDIC SURGEON HAD EXPERIENCED ANOTHER ISSUE WITH THE SURGICAL COVER DRESSING. MEETING ARRANGED TO MEET MR. (B)(6) THIS AM. ATTENDED MEETING WITH MICHELLE PLUMMER, CRITICAL CARE REP FOR THE AREA. CONSULTANT ORTHOPAEDIC SURGEON HAS STATED THAT THERE IS A PROBLEM WITH THE PRODUCT AND HE WILL NOT BE USING IT AGAIN ON ANY OF HIS PTS ALTHOUGH DID SUGGEST THAT THIS MAY BE A SUSPECT BATCH. PT ATTENDED FOR TOTAL KNEE ARTHROPLASTY ON FRIDAY (B)(6). THREE DAYS POST-OP BLISTERS WERE NOTED THROUGH THE DRESSING AND THE DRESSING WAS REMOVED. THESE WERE EVIDENT ON THE PERI-WOUND SKIN ALTHOUGH CONSULTANT ORTHOPAEDIC SURGEON COULD NOT SPECIFY WHETHER THEY OCCURRED UNDER THE DUODERM COMPONENT OR THE AQUACEL COMPONENT. A HAEMATOMA WAS ALSO IDENTIFIED AND THE PT WAS REFERRED TO THE PLASTIC SURGEON. PT HAD EVACUATION AND DEBRIDEMENT OF THE HAEMATOMA UNDER ANAESTHETIC AND THEREAFTER VAC THERAPY WAS APPLIED. THE WOUND IS NOW HEALING AND PT HAS BEEN DISCHARGED. CONSULTANT ORTHOPAEDIC SURGEON FEELS THE AQUACEL SCD IS DIRECTLY RESPONSIBLE FOR CAUSING THIS INCIDENT. IN THEATRE, CONSULTANT ORTHOPAEDIC SURGEON USED POVIDONE-IODINE SKIN PREP AND USES SUTURES (DERMABOND) TO CLOSE. THERE HAVE BEEN NO RECENT CHANGES TO PRACTICE APART FROM THE IMPLEMENTATION OF THE DRESSING. NO WOUND DRAIN WAS USED. THE PT HAD NO KNOWN ALLERGIES AND EXUDATE LEVELS WERE MINIMAL TO MODERATE (A LEVEL WHICH HE EXPECTED AND NOT EXCESSIVE). PHYSIOTHERAPY COMMENCED 2 DAYS POST OP AND HE IS NOT AWARE OF AN ELECTRONIC FLEXION MACHINE BEING USED. THE BLISTERS WERE LEFT INTACT AND NOT ASPIRATED. THE DRESSING HAD NOT BEEN WARMED PRIOR TO APPLICATION. MR. (B)(6) WAS NOT RECEPTIVE TO QUESTIONS AND DOES NOT WANT TO DISCUSS THE MATTER FURTHER BUT STATES HE WILL NEVER USE THE PRODUCT AGAIN. HE HAS USED IT ONLY ONCE, ON A HIP, WITH SUCCESS. THEATRES VISITED TO OBTAIN PRODUCT FROM SAME BATCH AS THAT USED ON THE PT. X 2 BOXES OF AQUACEL 4 X 30 AND X 2 DUODERM EXTRA THIN 9 X 35 SENT TO MICHELLE TO TAKE IN TO THEATRES SHOULD HE WISH TO USE IT. HE CONTINUES TO USE THE JUBILEE METHOD AT (B)(6) HOSP ON HIS NHS PTS WITH NO PROBLEMS. HE HAS REVERTED TO USING GAUZE AND BANDAGING ON HIS PRIVATE PTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AQUACEL SURGICAL COVER DRESSING ABSORBENT ANTIMICROBIAL WOUND DRESSING FRO CONVATEC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention