BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLOWABLE WOUND MATRIX - UNSPECIFIED

    MDR report key: 8217541 · Received January 4, 2019

    Report

    Report Number
    1121308-2019-00001
    Event Type
    Injury
    Date Received
    January 4, 2019
    Report Date
    December 7, 2018
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION
    Product Code
    KGN
    PMA / PMN Number
    K022127
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT LOT NUMBER WAS PROVIDED WITH THIS COMPLAINT; THEREFORE, DHR REVIEW CANNOT BE PERFORMED. ALL PRODUCT IS RELEASED BASED ON PASSING OF ALL IN PROCESS AND FINISHED GOODS CRITERIA. THIS INCLUDES ENSURING THAT STERILE PRODUCT GETS TO THE CUSTOMER. THE FAILURE IS UNCONFIRMED, AS THERE WAS NO PRODUCT RETURNED FOR THIS COMPLAINT. THEREFORE, FAILURE ANALYSIS COULD NOT BE PERFORMED.

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    SPRINGER (2017) PUBLISHED "TO EVALUATE THE EFFICACY OF AN ACELLULAR FLOWABLE MATRIX IN COMPARISON WITH A WET DRESSING FOR THE TREATMENT OF PATIENTS WITH DIABETIC FOOT ULCERS: A RANDOMIZED CLINICAL TRIAL." THE AUTHORS AIMED TO EVALUATE THE EFFICACY OF AN ADVANCED WOUND MATRIX (INTEGRA FLOWABLE WOUND MATRIX, INTEGRA LIFESCIENCE CORP) FOR TREATING WOUNDS WITH IRREGULAR GEOMETRIES VERSUS A WET DRESSING IN PATIENTS WITH DIABETIC FOOT ULCERS. SIXTY PATIENTS WITH DIABETIC FOOT ULCERS (GRADES 3 WAGNER) WERE INCLUDED IN THIS RANDOMIZED CLINICAL TRIAL. FORTY-SIX CASES OF DIABETIC FOOT ULCERS WERE EQUALLY AND RANDOMLY DIVIDED INTO CONTROL AND TEST GROUPS. THE FIRST GROUP TREATED WITH INTEGRA FLOWABLE WOUND MATRIX, WHILE THE CONTROL GROUP WITH A WET DRESSING. BOTH GROUPS WERE EVALUATED ONCE A WEEK FOR 6 WEEKS TO VALUE THE DEGREE OF EPITHELIALIZATION AND GRANULATION TISSUE OF THE WOUND. THE COMPLETE HEALING RATE IN THE WHOLE STUDY POPULATION WAS 69.56% (INTEGRA FLOWABLE WOUND MATRIX GROUP, 86.95%, CONTROL GROUP, 52.17%; P = 0.001). AMPUTATION AND REHOSPITALIZATION RATES WERE HIGHER IN THE CONTROL GROUP COMPARED TO THE FIRST GROUP, THEREFORE, THE DIFFERENCE WAS STATISTICALLY SIGNIFICANT. MINOR AMPUTATIONS WERE PERFORMED: NINE (39.13%) PATIENTS IN THE INTEGRA FLOWABLE GROUP AND EIGHT (34.78%) PATIENTS IN THE CONTROL GROUP. AFTER 6 WEEKS, THE OVERALL COMPLETE HEALING RATE AMONG ALL PATIENTS WAS 69.56%. COMPLETE WOUND HEALING AFTER 6 WEEKS (PRIMARY ENDPOINT), OCCURRED IN 20 PATIENTS (86.95%) OF THE INTEGRA FLOWABLE WOUND MATRIX GROUP AND IN 12 PATIENTS (52.17%) OF THE CONTROL GROUP. A SIGNIFICANT DIFFERENCE IN COMPLETE HEALING WAS OBSERVED BETWEEN THE TWO GROUPS AFTER 6 WEEKS. AFTER 6 WEEKS, 3 OF THE 23 PATIENTS (13.04%) IN THE INTEGRA FLOWABLE GROUP SHOWED NO HEALING, WITHOUT ANY CLINICAL SIGN OF INFLAMMATION (EDEMA, ERYTHEMA, INCREASED LOCAL TEMPERATURE, THE PRESENCE OF ABSCESS) AND/OR LABORATORY SIGNS OF INFLAMMATION. TIME TO HEALING (SECONDARY ENDPOINT) WAS BETWEEN: 29.73 ± 9.27 DAYS IN THE INTEGRA FLOWABLE GROUP AND 42.78 ± 8.22 DAYS IN THE CONTROL GROUP. MAJOR AMPUTATION AND REHOSPITALIZATION RATES (SAFETY ENDPOINTS) WERE HIGHER IN THE CONTROL GROUP COMPARED TO INTEGRA FLOWABLE WOUND MATRIX GROUP, CONCLUSION: THE RESULTS OF THE PRESENT STUDY DEMONSTRATED THE INTEGRA FLOWABLE TESTED CAN BE CONSIDERED AN EFFECTIVE ADJUNCTIVE TREATMENT IN THE PROMOTION OF WOUND HEALING IN THE PATIENTS WITH DFUS. THE INTEGRA FLOWABLE USED IN THIS STUDY ALLOWS THE TREATMENT OF TUNNELING/OR CAVITY LESIONS WITH AN IRREGULAR GEOMETRY OF THE DIABETIC FOOT, WHICH CANNOT BE EFFECTIVELY TREATED USING OTHER BIOMATERIALS IN THE SHEET FORM. FURTHERMORE, EASY APPLICATION, THE ABSENCE OF ADVERSE EFFECTS AND A MINIMALLY INVASIVE APPROACH BY PRIMARY INTENTION CLOSURE OF THE LESION, MAKE IT APPROPRIATE IN THE MANAGEMENT OF DFUS. THE INTEGRA FLOWABLE WOUND MATRIX, WAS SIGNIFICANTLY SUPERIOR, COMPARED TO THE WET DRESSING, BY PROMOTING THE COMPLETE HEALING OF DIABETIC FOOT ULCERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12957 FLOWABLE WOUND MATRIX - UNSPECIFIED N/A KGN INTEGRA LIFESCIENCES CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1