BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AQUACEL FOAM HYDROFIBER DRESSING, STERILE 4"

    MDR report key: 4924222 · Received July 16, 2015

    Report

    Report Number
    1049092-2015-00404
    Event Type
    Injury
    Date Received
    July 16, 2015
    Date of Event
    May 26, 2015
    Report Date
    June 24, 2015
    Manufacturer
    CONVATEC, LIMITED
    Product Code
    NAC
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON AUGUST 28, 2015. THIS ISSUE WAS INVESTIGATED BY CONFIRMING THE SILICONE TRILAMINATE (SKIN CONTACT MATERIAL) USED IN THIS LOT WAS CERTIFIED MEETING CONVATEC REQUIREMENTS. SECONDLY CONFIRMING THE STERILIZATION OF THE PRODUCT. THIRD REFERENCING THE SUMMARY OF HEALTH DATA FOR DOW CORNING SOFT SKIN ADHESIVE. ALL MANUFACTURING, MATERIALS AND STERILIZATION PROCESSES MET REQUIREMENTS. NO PREVIOUS INVESTIGATIONS ARE AVAILABLE. AFTER A THOROUGH BATCH REVIEW NO DISCREPANCIES OR NON-CONFORMANCES WERE DISCOVERED. THERE IS NOT ENOUGH INFORMATION TO CONCLUDE THE PRODUCT DID NOT MEET SPECIFICATION AND PERFORM AS INTENDED. PRODUCT MONITORING REVIEWS WILL MONITOR FOR PRODUCT TRENDS IF THIS ISSUE WERE TO REOCCUR. NO FURTHER ACTIONS ARE REQUIRED AND THE COMPLAINT WILL BE CLOSED. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFO, THIS EVENT IS DEEMED TO BE SERIOUS INJURY. NO ADDITIONAL PT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFO BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED AN AQUACEL AG EXTRA DRESSING WAS PLACED IN A WOUND BED TO TREAT CELLULITIS AND A SMALL ABSCESS ON PT'S RIGHT LEG. AN AQUACEL FOAM DRESSING WAS THEN ADHERED ON THE TOP OF THE DRESSING AND WOUND. SIX DAYS LATER, BOTH DRESSINGS WERE REMOVED. AT THAT TIME, THE NURSE NOTED THE WOULD ITSELF HAD "ALMOST HEALED" BUT THE PT'S PERIWOUND SKIN, WHICH HAD BEEN IN CONTACT WITH THE ADHESIVE PORTION OF THE AQUACEL FOAM DRESSING, WAS SORE, RED, IRRITATED AND HAD 3-4 BLISTERS. A PHYSICIAN EXAMINED THE AREA AND SUGGESTED THE PT HAD EXPERIENCED AN ALLERGIC REACTION TO THE AQUACEL DRESSING. A PRESCRIPTION FOR CLINDAMYCIN WAS ISSUED TO THE PT. THE PT'S WOUND WAS THEN TREATED WITH DRESSING FROM A DIFFERENT MANUFACTURER (INADINE AND MEPITEL). NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463828 AQUACEL FOAM HYDROFIBER DRESSING, STERILE 4" DRESSING, WOUND, HYDROPHILIC NAC CONVATEC, LIMITED 420680 2375740

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR Required Intervention