BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TCC-EZ UNKNOWN

    MDR report key: 18583984 · Received January 25, 2024

    Report

    Report Number
    9680091-2024-00001
    Event Type
    Injury
    Date Received
    January 25, 2024
    Report Date
    February 15, 2024
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    ITG
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    NO INVESTIGATION RESULTS: "JOURNAL ARTICLE WITH NO ALLEGATION OF PRODUCT DEFICIENCY." ADDITIONAL INFORMATION RECEIVED: "THE AERS WERE RELATED TO THE PATIENT CONDITION RATHER THAN THE DEVICES THEMSELVES, ALL CASES WERE PATIENTS WITH NEUROPATHIC FOOT ULCERATION AND DIABETES."

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    THE JOURNAL OF WOUND CARE (2023) PUBLISHED "THE SHORT-TERM IMPACT OF NON-REMOVABLE OFFLOADING DEVICES ON QUALITY OF LIFE IN PEOPLE WITH RECURRENT DIABETIC FOOT ULCERS." OBJECTIVE: "RECURRENT DIABETIC FOOT ULCERS (DFUS) ARE ASSOCIATED WITH POOR HEALTH-RELATED QUALITY OF LIFE AND REDUCED MOBILITY. CURRENT GUIDELINES RECOMMEND APPLICATION OF NON-REMOVABLE OFFLOADING DEVICES (NROLDS) AS THEY MAY IMPROVE THE HEALING OF DFUS, BUT THERE IS A LACK OF INFORMATION ON THE WIDER EFFECTS OF WEARING THESE DEVICES. FEW STUDIES HAVE EXAMINED THE IMPACT OF NROLDS ON HOLISTIC WELLBEING OR PHYSICAL ACTIVITY. WE AIMED TO INVESTIGATE THE SHORT-TERM IMPACT OF NROLDS ON PHYSICAL ACTIVITY AND DFU-RELATED QUALITY OF LIFE (DFU-QOL) IN A SMALL SAMPLE OF COMMUNITY-DWELLING PEOPLE WITH RECURRENT DFUS." METHOD: "WE MEASURED DFU-QOL AND PHYSICAL ACTIVITY (GPAQ) IN PEOPLE WITH DFUS, RECRUITED FROM A SINGLE CLINIC BEFORE NROLD APPLICATION, AND AT THREE AND SIX WEEKS AFTER DEVICE FITTING. PARTICIPANTS WERE AGED FROM 39¿81 YEARS (MEAN 58.4±10.1 YEARS) WITH AN EQUAL NUMBER OF MALE AND FEMALE PARTICIPANTS." RESULTS: "THE STUDY COHORT COMPRISED 18 PARTICIPANTS, OF WHOM 14 (78%) COMPLETED SIX-WEEK QUESTIONNAIRES. ALTHOUGH THERE WAS SOME INTERIM DECLINE OBSERVED WITHIN INDIVIDUAL DOMAINS OF THE DFU-QOL (FINANCIAL: MEAN DIFFERENCE (MD) 16.2 (95% CONFIDENCE INTERVAL (CI) 2.1, 30.2); P=0.03); NON-COMPLIANCE: MD 12.5 (95% CI¿0.2, 25.2); P=0.05), NO DIFFERENCES WERE OBSERVED OVER SIX WEEKS. LEVELS OF PHYSICAL ACTIVITY DECLINED OVER TIME, WITH OVER HALF (56%) OF PARTICIPANTS CLASSIFIED AS HAVING LOW LEVELS OF PHYSICAL ACTIVITY AT BASELINE, RISING TO TWO-THIRDS (67%) AT FOLLOW-UP." CONCLUSION: "FUTURE STUDIES SHOULD EXPLORE THE LONGER-TERM HOLISTIC IMPACT OF NROLDS AND DEVELOP MORE PERSONALIZED APPROACHES TO CARE AT THE POINT OF PRESCRIPTION, DURING AND POST-DEVICE USE." ADVERSE EVENT: ULCER INFECTION ¿ TWO PARTICIPANTS DEVELOPED ULCER INFECTION (SAME COMPLAINT FOR EACH PARTICIPANT) - NO FOLLOW UP INFORMATION PROVIDED ABOUT THE CARE OR TREATMENT, OR OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1120800 TCC-EZ UNKNOWN TCC-EZ ITG INTEGRA LIFESCIENCES CORPORATION OH/USA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown