BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLOWABLE WOUND MATRIX - UNSPECIFIED

    MDR report key: 10280812 · Received July 15, 2020

    Report

    Report Number
    1226348-2020-00284
    Event Type
    Injury
    Date Received
    July 15, 2020
    Report Date
    May 14, 2020
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION
    Product Code
    KGN
    PMA / PMN Number
    K072113
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT SAMPLE WAS NOT RETURNED FOR EVALUATION AND LOT NUMBER INFORMATION HAS NOT BEEN PROVIDED; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED, AND MANUFACTURING RECORDS COULD NOT BE REVIEWED. THE CAUSE(S) OF THE DIFFICULTY REPORTED BY THE CUSTOMER COULD NOT BE DETERMINED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED.

    Description of Event or Problem · 1

    ADVANCES IN SKIN & WOUND CARE (B)(6) 2018) PUBLISHED: ACELLULAR FLOWABLE MATRIX IN THE TREATMENT OF TUNNELED OR CAVITY ULCERS IN DIABETIC FEET: A PRELIMINARY REPORT. OBJECTIVE: THE AUTHORS AIMED TO EXPLORE THE FEASIBILITY AND SAFETY OF AN ADVANCED, ACELLULAR, FLOWABLE WOUND MATRIX (FWM) IN PATIENTS WITH DIABETES-RELATED CAVITY OR TUNNEL LESIONS INVOLVING DEEP STRUCTURES. METHODS: PATIENTS WITH DIABETIC FOOT ULCERS WERE HOSPITALIZED AT THE GENERAL AND GERIATRIC SURGERY UNIT OF (B)(6), BETWEEN (B)(6) 2015 AND (B)(6) 2015. TWENTY-THREE PATIENTS WITH TUNNELED OR CAVITY ULCERS WERE TREATED. THE LESIONS WERE FILLED WITH THE FWM. SURGICAL WOUND EDGES WERE EITHER APPROXIMATED WITH STITCHES OR LEFT TO HEAL BY SECONDARY INTENTION. RESULTS: AFTER 6 WEEKS, 78.26% OF PATIENTS COMPLETELY HEALED AFTER A SINGLE APPLICATION OF THE FWM. THE HEALING TIME FOR ALL HEALED WOUNDS WAS 30.85 T 12.62 DAYS, OR 26.11 T 5.43 DAYS IN PATIENTS FOR WHOM WOUND EDGES WERE APPROXIMATED BY STITCHES, AND 57.66 T 3.05 DAYS IN THE PATIENTS WHO HEALED BY SECONDARY INTENTION (P = .01). PERMANENT TISSUE REGENERATION WAS OBSERVED IN A HIGH PERCENTAGE OF PATIENTS, AND SHORTER HEALING TIME WAS ACHIEVED. STUDY AUTHORS OBSERVED A LOW RATE OF COMPLICATIONS SUCH AS MAJOR AMPUTATION AND INCREASED HOSPITALIZATION. ADVERSE EVENT: MAJOR AMPUTATION. ONE PATIENT WITH NO WOUND HEALING UNDERWENT A MAJOR AMPUTATION. CONCLUSIONS: THE FWM SEEMS IDEAL FOR TUNNELED AND CAVITY ULCERS WITH IRREGULAR GEOMETRY. THIS NEW POROUS MATRIX ALLOWS CLOSURE OF THE LESION WHILE REDUCING HEALING TIME AND DEMOLITION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738424 FLOWABLE WOUND MATRIX - UNSPECIFIED N/A KGN INTEGRA LIFESCIENCES CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1