BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN REVOLVE

    MDR report key: 17725546 · Received September 11, 2023

    Report

    Report Number
    1000306051-2021-00004
    Event Type
    Injury
    Date Received
    September 11, 2023
    Report Date
    September 11, 2023
    Manufacturer
    LIFECELL
    Product Code
    MUU
    PMA / PMN Number
    K120902
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NASHVILLE. ¿COMPARISON OF TELFA ROLLING AND A CLOSED WASHING SYSTEM FOR ... : PLASTIC AND RECONSTRUCTIVE SURGERY.¿ LWW, JOURNALS.LWW.COM/PLASRECONSURG/FULLTEXT/2020/09000/COMPARISON_OF_TELFA_ROLLING_AND_A_CLOSED_WASHING.4.ASPX. ADDITIONAL INFORMATION: H.6 F2303. THIS EVENT IS BEING REPORTED FOR SERIOUS INJURY. FOLLOW UPS WERE PERFORMED WITH CORRESPONDENT AUTHOR AND TO DATE, NO RESPONSE WAS PROVIDED. DEVICES WERE NOT RETURNED FOR EVALUATION. LOT (S) NUMBER REMAINS UNKNOWN; THEREFORE, NO INTERNAL INVESTIGATION CAN BE PERFORMED. BASED ON THE AVAILABLE INFORMATION, A RELATIONSHIP BETWEEN THE REVOLVE DEVICE (S) AND THE EVENT CANNOT BE DETERMINED. IF ADDITIONAL INFORMATION IS PROVIDED, A FOLLOW UP REPORT WILL BE SEND. NO FURTHER ACTIONS ARE REQUIRED AS A NONCONFORMANCE COULD NOT BE CONFIRMED.

    Description of Event or Problem · 0

    DURING A LITERATURE REVIEW OF AN ARTICLE TITLED, ¿COMPARISON OF TELFA ROLLING AND A CLOSED WASHING SYSTEM FOR AUTOLOGOUS FAT PROCESSING TECHNIQUES IN POSTMASTECTOMY BREAST RECONSTRUCTION¿ A STUDY OF 186 PATIENTS PERFORMED FROM JANUARY 2013 TO SEPTEMBER 2017 AIMED TO COMPARE THE COMMONLY USED FAT GRAFTING TECHNIQUES¿TELFA ROLLING AND A CLOSED WASHING SYSTEM¿IN BREAST RECONSTRUCTION PATIENTS. THE RESULT OF THE STUDY REVEALED THAT THERE WAS NO DIFFERENCE IN DEMOGRAPHICS, NUMBER OF PROCEDURES PERFORMED, VOLUME OF FAT GRAFTED, AND NUMBER OF DAYS AFTER RECONSTRUCTION THAT FAT GRAFTING WAS PERFORMED BETWEEN GROUPS (P > 0.05). TELFA ROLLING PATIENTS HAD LONGER OPERATIVE TIMES FOR SECOND FAT GRAFTING PROCEDURES (IMPLANT EXCHANGE OFTEN COMPLETED PRIOR) [100.0 MINUTES (RANGE, 60.0 TO 150.0 MINUTES) VERSUS 79.0 MINUTES (RANGE,64.0 TO 94.0 MINUTES); P = 0.03]. TELFA ROLLING BREASTS HAD MORE PALPABLE MASSES REQUIRING IMAGING (26.0 PERCENT VERSUS 14.4 PERCENT; P = 0.01) AND AN INCREASED INCIDENCE OF FAT NECROSIS (20.6 PERCENT VERSUS 8.0 PERCENT; P < 0.01). THE CLOSED WASHING SYSTEM WAS FOUND TO BE AN INDEPENDENT PREDICTOR OF DECREASED RATES OF IMAGING-CONFIRMED FAT NECROSIS (OR, 0.29; P = 0.048). THERE WAS NO DIFFERENCE IN FAT NECROSIS EXCISION OR CANCER RECURRENCE BETWEEN THE GROUPS. SOME OF THE PATIENTS HAD THE FOLLOWING COMPLICATIONS: SURGICAL SITE INFECTION REQUIRING ORAL AND IV ANTIBIOTICS, DRAINAGE, SEROMA, HEMATOMA, SKIN NECROSIS, PALPABLE MASS REQUIRING CORE BIOPSY AND PERSISTENT PAIN. CONCLUSION: THE CLOSED WASHING SYSTEM WAS INDEPENDENTLY ASSOCIATED WITH DECREASED RATES OF IMAGING-CONFIRMED FAT NECROSIS COMPARED TO TELFA ROLLING WITHOUT AN INCREASE IN OTHER COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1890524 UNKNOWN REVOLVE SYSTEM, SUCTION, LIPOPLASTY MUU LIFECELL NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown