BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NATURA

    MDR report key: 19190723 · Received April 26, 2024

    Report

    Report Number
    9618003-2024-00742
    Event Type
    Injury
    Date Received
    April 26, 2024
    Date of Event
    January 29, 2024
    Report Date
    April 16, 2024
    Manufacturer
    CONVATEC DOMINICAN REPUBLIC INC
    Product Code
    EXE
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    E1: COMPLAINANT STREET ADDRESS: (B)(6), COMPLAINANT CITY: (B)(6), COMPLAINANT STATE/PROVINCE: (B)(6), COMPLAINANT POSTAL CODE: (B)(6), COMPLAINANT COUNTRY: CANADA, COMPLAINANT PHONE: (B)(6), NAME OF HOSPITAL: (B)(6) HOSPITAL. BRAND NAME OF DRESSING: AQUACEL AG (AQAG) BRAND NAME OF ANOTHER COMPANY PRODUCT: HOLLISTER 7700 BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. THIS COMPLAINT HAS BEEN EVALUATED. NO LOT NUMBER IS AVAILABLE. A DETAILED INVESTIGATION OR BATCH REVIEW CANNOT BE CONDUCTED. THEREFORE, THIS EVALUATION WILL BE CLOSED. THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET PRODUCT MONITORING REVIEW PROCESS. TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. FDA REGISTRATION NUMBER REPORTING SITE: 1049092 MANUFACTURING SITE: 9618003.

    Description of Event or Problem · 0

    THE END USER STATED THAT SHE HAD BEEN STRUGGLING SINCE FEBRUARY WITH A SKIN TEAR THAT WAS NOT HEALING. SHE SAID SHE HAD GONE TO REMOVE HER COMPANY'S WAFER THAT IT RIPPED HER SKIN. AT THE TIME, SHE THOUGHT IT WAS DUE TO HER AGING SKIN. SHE DESCRIBED THE ULCER AS BEING THE SIZE OF A NICKEL BUT STRETCHED OVAL THAT WAS OCCURRED IN END OF JANUARY. DURING HER LAST VISIT, THE ULCER HAD DEVELOPED HYPER GRANULATION, SO IT WAS BURNED AND TREATED WITH SILVER NITRATE. ADDITIONALLY, IT WAS REPORTED THAT THE PATIENT HAD VISITED THE EMERGENCY ROOM (ER) WHERE SHE RECEIVED ANTIBIOTICS AS PART OF HER TREATMENT. A COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED TO ASSESS THE PRESENCE OF A FISTULA, AND THE RESULTS CAME BACK NORMAL, INDICATING NO EVIDENCE OF A FISTULA WAS FOUND. AFTER THEN, SHE HAD BEEN USING SILVER NITRATE POWDER, DRESSING AND ANOTHER COMPANY PROTECTIVE SQUARE WAFER ON TOP PRIOR TO APPLICATION OF COMPANY'S WAFER, CHANGING THEM EVERY ONE TO TWO DAYS. AS THE END USER HAS A MEDICAL HISTORY OF CROHN'S AND RHEUMATOID ARTHRITIS, SHE ASKED IF THE HEALTHCARE PROVIDERS HAD RULED OUT OTHER POTENTIAL CAUSES FOR THE ULCER, SUCH AS PYODERMA. HOWEVER, SHE STATED THAT SHE HAD BEEN SEEN BY THREE NURSE SPECIALIZED IN WOUND, OSTOMY AND CONTINENCE (NSWOC'S) WORKING FOR HER LOCAL HOMECARE AND THEY DID NOT MENTION ANY OTHER ISSUES. MOREOVER, IT WAS ANALYSED THAT PRE-EXISTING MEDICAL CONDITIONS CONTRIBUTED TO THE HEALING OF THE SKIN, AND OVER A PERIOD OF TIME, HYPER GRANULATION OCCURRED. NO PHOTO WAS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2123280 NATURA PROTECTOR, OSTOMY EXE CONVATEC DOMINICAN REPUBLIC INC 413183

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female