BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUACEL® FOAM DRESSING, ADHESIVE, SURGICAL

    MDR report key: 5539639 · Received March 31, 2016

    Report

    Report Number
    1049092-2016-00135
    Event Type
    Malfunction
    Date Received
    March 31, 2016
    Report Date
    March 10, 2016
    Manufacturer
    CONVATEC INC.
    Product Code
    NAC
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PREVIOUS INVESTIGATIONS ARE AVAILABLE. AFTER THE DETAILED BATCH REVIEW ON LOT# 2393009, 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 WILL MONITOR FOR PRODUCT TRENDS IF THIS ISSUE WERE TO REOCCUR. NO FURTHER ACTIONS ARE REQUIRED, AND THE COMPLAINT WILL BE CLOSED. EDUCATIONAL NOTES: 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 MT14-068 AND/OR MT14-073. THIS LOT OF PRODUCT WAS STERILIZATION CERTIFIED AND ALL MANUFACTURING, MATERIALS, AND STERILIZATION PROCESSES WERE COMPLIANT TO REQUIREMENTS. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. BASED ON THE AVAILABLE INFORMATION, NO PATIENT HARM OCCURRED. FOLLOW UP HAS BEEN REQUESTED, BUT NO ADDITIONAL DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. REPORTED TO THE FDA ON MARCH 31, 2015. (B)(4). NOTE: TWO CASES ASSOCIATED WITH THIS COMPLAINT. A SEPARATE FDA FORM 3500A HAS BEEN COMPLETED FOR THE UNKNOWN AMOUNT OF DRESSINGS, UNKNOWN NUMBER OF PATIENTS AND UNKNOWN LOT NUMBERS ASSOCIATED WITH THIS COMPLAINT.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED FROM A WOUND CARE NURSE REPORTING AN ADHESIVE ISSUE WITH THE DRESSING. REPORTER STATED THAT THE DRESSING WAS USED IN THE SPINAL SURGERY WARD TO DRESS A SURGICAL INCISION TO A PATIENT'S SPINE. REPORTER STATED THE DRESSING "COMES OFF A DIFFERENT WAY AND FASTER," IN LESS THAN TWO (2) DAYS. AT FOLLOW-UP THE STATEMENT WAS CLARIFIED TO MEAN "THE DRESSING ROLLS UP AND DOES NOT STICK." REPORTER STATED THAT THE PRODUCT HAD BEEN DISCARDED, BUT THAT A DRESSING FROM THE SAME LOT WAS BEING RETURNED. REPORTER PROVIDED NO FURTHER DETAILS INCLUDING PATIENT TREATMENT OR OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195739 AQUACEL® FOAM DRESSING, ADHESIVE, SURGICAL DRESSING, WOUND, HYDROPHILIC NAC CONVATEC INC. 421155 2393009

    Patients

    Seq Age Sex Outcome Treatment
    1