BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREVENA INCISION MANAGEMENT SYSTEM

    MDR report key: 12204905 · Received July 21, 2021

    Report

    Report Number
    3009897021-2021-00176
    Event Type
    Injury
    Date Received
    July 21, 2021
    Date of Event
    July 1, 2015
    Report Date
    July 21, 2021
    Manufacturer
    KINETIC CONCEPTS, INC.
    Product Code
    OMP
    PMA / PMN Number
    K100821
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT, DATE OF BIRTH: THE PATIENT AGES WERE NOT PROVIDED. THE ARTICLE NOTED THE MEAN AGE: 73.9 YEARS, THUS 74 YEARS WAS UTILIZED. SEX: FEMALES AND MALES WERE INCLUDED IN THIS STUDY. DATE OF EVENT: THE DATE OF THE EVENTS WAS NOT PROVIDED. THE ARTICLE NOTED THE DATA WAS RETROSPECTIVELY ON PATIENTS WITH WOUND CLOSURES FROM JULY 2015 TO JUNE 2019, THUS THE DATE 01-JUL-2015 WAS UTILIZED. OTHER (CODE UNSPECIFIED, DESCRIBE IN H10): DEVICE IDENTIFIERS WERE NOT PROVIDED, AND THE DEVICES WERE NOT RETURNED FOR EVALUATION. BASED ON INFORMATION PROVIDED, IT CANNOT BE DETERMINED THAT THE ALLEGED RE-OPERATIONS ARE RELATED TO THE PREVENA¿ INCISION MANAGEMENT SYSTEM. THE ARTICLE NOTED TYPES OF VASCULAR SURGERY, 5 TYPES OF BYPASS SURGICAL PROCEDURES AS WELL AS FEMORAL ENDARTERECTOMY WERE INDICATED. THE ARTICLE NOTED, "WHILE THIS NUMBER WAS NOT STATISTICALLY SIGNIFICANT BETWEEN THE NPD AND NON-NPD GROUP; THERE WAS STILL A HIGHER NUMBER OF INTERVENTIONS REQUIRED FOR WOUND COMPLICATIONS IN THE NON-NPD GROUP. KCI HAS MADE MULTIPLE UNSUCCESSFUL ATTEMPTS TO OBTAIN ADDITIONAL CLINICAL AND DEVICE INFORMATION. DEVICE LABELING, AVAILABLE IN PRINT AND ONLINE, STATES: THE PREVENA¿ INCISION MANAGEMENT SYSTEM WILL NOT BE EFFECTIVE IN ADDRESSING COMPLICATIONS ASSOCIATED WITH THE FOLLOWING: ISCHEMIA TO THE INCISION OR INCISION AREA. UNTREATED OR INADEQUATELY TREATED INFECTION. INADEQUATE HEMOSTASIS OF THE INCISION. CELLULITIS OF THE INCISION AREA. DRESSING CHANGES: DRESSING CHANGES SHOULD OCCUR EVERY 24-72 HOURS, OR MORE FREQUENTLY BASED ON A CONTINUING EVALUATION OF WOUND CONDITION AND PATIENT PRESENTATION. CONSIDER MORE FREQUENT DRESSING CHANGES IN THE PRESENCE OF INFECTION OR ABDOMINAL CONTAMINATION. DRESSING REMOVAL: REMOVE AND DISCARD PREVIOUS DRESSING PER INSTITUTION PROTOCOL. COMPLETELY INSPECT WOUND, INCLUDING PARCOLIC GUTTERS, TO ENSURE ALL PIECES OF DRESSING COMPONENTS HAVE BEEN REMOVED. IF INTRA-ABDOMINAL PACKING MATERIAL IS PRESENT, PACKING MATERIAL MAY BE DRIER THAN ANTICIPATED. EVALUATE PACKING MATERIAL PRIOR TO REMOVAL AND REHYDRATE IF NECESSARY, TO PREVENT ADHERENCE OR DAMAGE TO ADJACENT STRUCTURES. THE PREVENA¿ INCISION MANAGEMENT SYSTEM SHOULD NOT BE USED TO TREAT OPEN OR DEHISCED SURGICAL WOUNDS OR ON PATIENTS WHO HAVE EXCESSIVE AMOUNTS OF EXUDATE FROM THE INCISION AREA WHICH MAY EXCEED THE PREVENA¿ 45ML CANISTER. FOR MAXIMUM BENEFIT THE PREVENA PLUS¿ THERAPY SYSTEM SHOULD BE APPLIED IMMEDIATELY POST-SURGERY TO CLEAN SURGICALLY CLOSED WOUNDS.

    Description of Event or Problem · 1

    ON 23-JUN-2021, THE FOLLOWING INFORMATION WAS RECEIVED BY KCI AFTER A REVIEW OF JOURNAL ARTICLE, LAURA J. MEILER, ELSWORTH C. BEACH, BHAKTI CHAVAN, KRISTEN J. CONRAD-SCHNETZ, JEFFREY A. STANLEY, NICOLE D. RAMON. BENEFIT OF NEGATIVE PRESSURE DRESSINGS IN VASCULAR SURGERY PATIENTS WITH INFRA-INGUINAL 1 INCISIONS AFTER SHORT-TERM FOLLOWUP ASSESSING THE BENEFIT OF INCISIONAL NEGATIVE PRESSURE 2 DRESSINGS IN COMMUNITY-BASED VASCULAR SURGERY PATIENTS WITH INFRA-INGUINAL INCISIONS. J VASC SURG. 2021 MAY 18: S0741-5214(21)00738-2. DOI: 10.1016/J.JVS.2021.04.058 NOTED THE FOLLOWING: UNDER TABLE 2: 3 PATIENTS REQUIRED RE-OPERATION. TYPE OF VASCULAR SURGERY LISTED 5 TYPES OF BYPASS SURGICAL PROCEDURES AS WELL AS FEMORAL ENDARTERECTOMY. THE ARTICLE NOTED, "WHILE THIS NUMBER WAS NOT STATISTICALLY SIGNIFICANT BETWEEN THE NPD [NEGATIVE PRESSURE DRESSING] AND NON-NPD GROUP; THERE WAS STILL A HIGHER NUMBER OF INTERVENTIONS REQUIRED FOR WOUND COMPLICATIONS IN THE NON-NPD GROUP ... WITHIN THE VASCULAR PATIENT POPULATION THERE IS INCREASED RISK OF DEVELOPING WOUND COMPLICATIONS ESPECIALLY IN INFRA-INGUINAL INCISIONS. NO ADDITIONAL INFORMATION WAS PROVIDED. THE PREVENA¿ INCISION MANAGEMENT SYSTEM IDENTIFIERS WERE NOT PROVIDED, THEREFORE DEVICE EVALUATIONS AND DEVICE HISTORY RECORD REVIEWS CANNOT BE COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1098046 PREVENA INCISION MANAGEMENT SYSTEM OMP OMP KINETIC CONCEPTS, INC. WNDPRV NI

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention