BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUODERM® EXTRA THIN CGF® HYDROCOLLOID DRESSING

    MDR report key: 5255214 · Received November 30, 2015

    Report

    Report Number
    1049092-2015-00680
    Event Type
    Injury
    Date Received
    November 30, 2015
    Date of Event
    November 9, 2015
    Report Date
    November 11, 2015
    Manufacturer
    CONVATEC, INC.
    Product Code
    NAD
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. 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

    ADDITIONAL INFORMATION TO CLARIFY EVENT DETAILS: DUODERM EXTRA THIN WAS APPLIED ON (B)(6). THAT DRESSING WAS CHANGED ON (B)(6) AND A DUODERM CFG WAS APPLIED ON (B)(6). THIS WAS REMOVED AND THE PRESSURE ULCER WAS IDENTIFIED. THE DATE IN WHICH THE SECOND DUODERM EXTRA THIN WAS APPLIED IS UNKNOWN BECAUSE IT WAS NOT RECORDED IN THE PATIENT'S CLINICAL HISTORY. THE HOSPITAL CONFIRMED THAT THE PRESSURE ULCERS ARE BEING TREATED WITH DUODERM GEL AND DUODERM CFG. NO LOT NUMBER OR PRODUCT EVALUATION SAMPLE IS AVAILABLE. A DETAILED INVESTIGATION OR BATCH REVIEW CANNOT BE CONDUCTED. THEREFORE THIS EVALUATION WILL BE CLOSED AND WILL BE MONITORED THROUGH OUR POST MARKET PRODUCT MONITORING REVIEW PROCESS. 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 PATIENT WAS HOSPITALIZED ON AN (B)(6) 2015, DUE TO ABDOMINAL SEPSIS "PRODUCED BY A PARTIAL DEHISCENCE OF A SUTURE OF THE SMALL INTESTINE FOLLOWING BLADDER ENLARGEMENT SURGERY." ON (B)(6) 2015, DURING HER HOSPITALIZATION, HEALTH CARE PROFESSIONALS PLACED A DUODERM EXTRA THIN CGF HYDROCOLLOID DRESSING IN THE SACRUM REGION DUE TO A SKIN PRESSURE SORE WITHOUT TISSUE LOSS. PRIOR TO APPLICATION OF THE DRESSING, A PHYSICAL EXAMINATION OF THE SACRAL REGION ALSO REVEALED A PROMINENT BONE PROTUBERANCE AND REMAINS OF A PREVIOUS SORE. THE DRESSING WAS SECURED WITH TEGADERM AND MICROPORE TAPE PRODUCTS. THE DRESSING WAS REMOVED AND REPLACED WITH A NEW DUODERM EXTRA THIN CGF HYDROCOLLOID DRESSING ON AN UNKNOWN DATE. NO INFORMATION REGARDING THE PATIENT'S SKIN INTEGRITY WAS RECORDED. THE DRESSING WAS SECURED WITH TEGADERM AND MICROPORE TAPE PRODUCTS. ON (B)(6) 2015, THE DRESSING WAS REMOVED AND REPLACED WITH A DUODERM CGF HYDROCOLLOID DRESSING. AGAIN THE DRESSING WAS SECURED WITH TEGADERM AND MICROPORE TAPE PRODUCTS. NO INFORMATION REGARDING THE PATIENT'S SKIN INTEGRITY WAS RECORDED. ON (B)(6) 2015, THE DRESSING WAS REMOVED. UPON REMOVAL, THE HOSPITAL STAFF NOTED STAGE IV PRESSURE ULCERS, NECROTIC TISSUE AND LOSS OF SKIN TISSUE INTEGRITY TO THE SACRUM REGION. THE NURSE ADVISED THAT THE ULCER AND SURROUNDING NECROTIC TISSUE WILL BE TREATED VIA DEBRIDEMENT. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    785999 DUODERM® EXTRA THIN CGF® HYDROCOLLOID DRESSING DRESSING, WOUND, OCCLUSIVE NAD CONVATEC, INC. 187957

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Required Intervention| S