BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUACEL FOAM ADH 8X13CM (1X10) EUR

    MDR report key: 4861610 · Received June 22, 2015

    Report

    Report Number
    1049092-2015-00355
    Event Type
    Malfunction
    Date Received
    June 22, 2015
    Date of Event
    April 1, 2015
    Report Date
    April 10, 2015
    Manufacturer
    CONVATEC INC.
    Product Code
    NAC
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    ADDITIONAL: ADHESION PROPERTIES DEPEND ON PROPER PREPARATION AND CLEANSING OF THE SKIN, FOLLOWED BY PROPER PREPARATION AND APPLICATION OF THE DRESSING TO THE SKIN. APPROPRIATE DRESSING SIZE AND SHAPE SHOULD BE USED TO ENSURE THE CENTRAL ABSORBENT PAD (AREA WITHIN THE ADHESIVE WINDOW) IS LARGER THAN THE WOUND AREA. AQUACEL FOAM DRESSINGS ARE MANUFACTURED USING MEDICAL GRADE ADHESIVE AND OTHER RAW MATERIALS THAT HAVE BEEN APPROVED FOR SKIN CONTACT. THIS COMPLAINT WAS INVESTIGATED BY CONFIRMING THE SILICONE TRILAMINATE,THE SKIN CONTACT MATERIAL, USED IN THIS LOT OF PRODUCT WAS CERTIFIED MEETING THE REQUIREMENTS OF CONVATEC. THIS LOT OF PRODUCT WAS STERILIZATION CERTIFIED AND ALL MANUFACTURING, MATERIALS, AND STERILIZATION PROCESSES WERE COMPLIANT TO REQUIREMENTS. NO PREVIOUS INVESTIGATIONS ARE AVAILABLE. AFTER THE DETAILED BATCH REVIEW, NO DISCREPANCIES (INCLUDING NON-CONFORMANCES/DEVIATIONS) WERE FOUND. 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT UNDERWENT THORACIC SURGERY. AN AQUACEL FOAM DRESSING WAS APPLIED POST-OPERATIVE TO THE SURGICAL INCISION(S) MADE TO THE PT'S THORACIC AREA AND LOWER LEG. THE DRESSING REPORTEDLY "FELL OFF" WITHIN 24 HOURS OF THE INITIAL APPLICATION. NO PT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403125 AQUACEL FOAM ADH 8X13CM (1X10) EUR DRESSING, WOUND, HYDROPHILIC NAC CONVATEC INC. 421149 2346574

    Patients

    Seq Age Sex Outcome Treatment
    1