BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVOLVE

    MDR report key: 5012021 · Received August 18, 2015

    Report

    Report Number
    1000306051-2015-00036
    Event Type
    Injury
    Date Received
    August 18, 2015
    Report Date
    July 23, 2015
    Manufacturer
    LIFECELL CORPORATION
    Product Code
    MUU
    PMA / PMN Number
    K120902
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: ACTUAL DEVICE NOT EVALUATED: THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO DEVICE LOT NUMBER COULD BE OBTAINED TO PERFORM A MANUFACTURING REVIEW. RESULTS: NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED: NO DEVICE EVALUATION OR QA INVESTIGATION COULD BE PERFORMED DUE TO THE LIMITED INFORMATION RECEIVED. CONCLUSION: DEVICE NOT RETURNED. BASED ON THE LIMITED INFORMATION REPORTED, NO QA INVESTIGATION COULD BE PERFORMED. THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER REMAINS UNKNOWN. ADDITIONAL PATIENT AND PROCEDURE SPECIFIC INFORMATION WAS REQUESTED, BUT TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. NO CULTURE RESULTS WERE RECEIVED TO CONFIRM THE REPORTED INFECTION. A RELATIONSHIP BETWEEN THE EVENT AND THE DEVICE COULD NOT BE DETERMINED. IF ADDITIONAL INFORMATION IS RECEIVED, THE INVESTIGATION WILL BE REOPENED AND A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    LIMITED INFORMATION WAS REPORTED TO LIFECELL ASSOCIATED WITH A PATIENT THAT DEVELOPED AN INFECTION FOLLOWING A FAT GRAFTING PROCEDURE WITH THE USE OF REVOLVE. NO OTHER LIFECELL PRODUCTS WERE USED IN THIS BREAST REVISION SURGERY AND IT WAS CONFIRMED THAT THE INFECTION DEVELOPED AT THE BREAST SITE, NOT THE FAT EXTRACTION SITE (ABDOMEN). ADDITIONAL PATIENT AND PROCEDURE SPECIFIC INFORMATION WAS REQUESTED, BUT TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. IT WAS REPORTED THAT THE LOT NUMBER OF THE DEVICE WAS NOT DOCUMENTED IN THE PATIENT'S RECORDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    544373 REVOLVE SYSTEM, SUCTION, LIPOPLASTY MUU LIFECELL CORPORATION RV0001 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention