BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUACEL AG FOAM HYDROFIBER DRESSING

    MDR report key: 5150618 · Received October 14, 2015

    Report

    Report Number
    1049092-2015-00604
    Event Type
    Malfunction
    Date Received
    October 14, 2015
    Report Date
    September 17, 2015
    Manufacturer
    CONVATEC, INC.
    Product Code
    FRO
    PMA / PMN Number
    K123481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON OCTOBER 30, 2015. THIS ISSUE WAS INVESTIGATED BY CONFIRMING THE SILICONE TRILAMINATE, THE SKIN CONTACT MATERIAL, USED IN THIS LOT OF PRODUCT WAS CERTIFIED MEETING THE REQUIREMENTS OF CONVATEC. CONFIRMING THE LOT OF PRODUCT WAS STERILIZATION CERTIFIED; AND REFERENCING SUMMARY OF HEALTH DATA FOR DOW CORNING® MG SOFT SKIN ADHESIVE. ALL MANUFACTURING, MATERIALS, AND STERILIZATION PROCESS 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. (B)(4).

    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 INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED. NOTE: THERE WERE REPORTEDLY 6 DEVICES AFFECTED BY THIS ISSUE. A SEPARATE FDA FORM 3500A OR ITS ELECTRONIC EQUIVALENT HAS BEEN SUBMITTED FOR EACH DEVICE. DATE OF EVENT: (B)(6) 2015. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SILICONE ADHESIVE BORDER OF THE DRESSING DID NOT ADHERE DURING USE. THE DRESSING CAME OFF AFTER 1 DAY OF WEAR. THE DRESSING WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678561 AQUACEL AG FOAM HYDROFIBER DRESSING DRESSING, WOUND, DRUG FRO CONVATEC, INC. 420805 2381347

    Patients

    Seq Age Sex Outcome Treatment
    1