BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVOLVE (OEM VERSION OF GID 700)

    MDR report key: 3796513 · Received April 18, 2014

    Report

    Report Number
    3009964461-2013-00003
    Event Type
    Injury
    Date Received
    April 18, 2014
    Date of Event
    February 25, 2014
    Report Date
    April 18, 2014
    Manufacturer
    THE GID GROUP INC.
    Product Code
    MUU
    PMA / PMN Number
    K120902
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED PT CODE: (INFLAMMATION), AND NOT CELLULITIS, BACTERIAL, BECAUSE LAB RESULTS NEGATIVE FOR BACTERIAL GROWTH. REVIEW OF THE PROCESSING HISTORY RECORDS FOR LOT 10331: LOT STERILIZATION DOSAGE WAS WITHIN SPECIFIED PARAMETERS. PACKAGING STERILE BARRIER SEALS WERE ACCEPTABLE FOR QUALITY RELEASE. NO PROCESS DEVIATIONS IN ASSOCIATION WITH THE MFR OF LOT 10331 WERE REVEALED THAT COULD HAVE ADVERSELY IMPACTED PRODUCT QUALITY. TO DATE OF THE 400 REVOLVE UNITS THAT WERE PROCESSED AND DISTRIBUTED FOR LOT 10331, NO OTHER REPORTS OF INFECTION HAVE BEEN REPORTED. IN GENERAL, THE POTENTIAL FOR INFECTION OR INFLAMMATORY RESPONSE IN THE SURGICAL SITE IS A FUNCTION OF STERILITY OF MANY INSTRUMENTS, DEVICES AND TECHNIQUES. BASED ON OUR INTERNAL INVESTIGATION WITH NO EVIDENCE OF PROCESS DEVIATIONS OR DEVICE MALFUNCTIONS, AND NO OTHER REPORTS OF INFECTIONS FROM LOT 10331, AS WELL AS CULTURE RESULTS FROM PATIENT BEING NEGATIVE, IT IS HIGHLY UNLIKELY THAT THIS EVENT IS RELATED TO THE REVOLVE DEVICE.

    Description of Event or Problem · 1

    ON (B)(6) 2014, LIFECELL (DISTRIBUTOR OF DEVICE) REPORTED: "IT WAS REPORTED TO LIFECELL THAT FOLLOWING A FAT GRAFTING PROCEDURE, THE PATIENT, DEVELOPED CELLULITIS." ON (B)(6) 2014, LIFECELL ADDITIONALLY REPORTED: CELLULITIS SYMPTOMS PRESENTED ONE WEEK POST-OP; PATIENT HAD PREVIOUS RADIATION OF RIGHT BREAST AND TWO PREVIOUS FAT GRAFTING PROCEDURES THAT WERE UNEVENTFUL; CULTURES WERE TAKEN, SHOWED NO GROWTH; PATIENT WAS TREATED WITH ANTIBIOTICS; FULLY RESOLVED, PATIENT IS FINE'. ON (B)(6) 2014, GID SPOKE DIRECTLY WITH PHYSICIAN DR. (B)(6): CONFIRMED INFO PROVIDED BY LIFECELL; ADD'L INFO INJECTED SALINE INTO CLOSED SUBCUTANEOUS CELLULITIS SITE, ASPIRATED SAMPLE AND SENT TO LAB, SAMPLE CAME BACK NEGATIVE PRIOR TO ADMINISTRATION OF ANTIBIOTICS; PATIENT SEEN BY INFECTIOUS DISEASE SPECIALIST AND TREATED WITH ANTIBIOTICS; NOTHING TO INDICATE REVOLVE AS THE SOURCE OF CELLULITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237202 REVOLVE (OEM VERSION OF GID 700) SYSTEM, SUCTION, LIPOPLASTY MUU THE GID GROUP INC. RV0004 10331

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other