BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIFECELL REVOLVE (OEM VERSION OF GID 700)

    MDR report key: 3341935 · Received July 27, 2013

    Report

    Report Number
    3009964461-2013-00001
    Event Type
    Other
    Date Received
    July 27, 2013
    Date of Event
    June 12, 2013
    Report Date
    July 26, 2013
    Manufacturer
    THE GID GROUP INC.
    Product Code
    MUU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    POSSIBLE INFECTION IN THE SURGICAL SITE IS A FUNCTION OF STERILITY OF MANY INSTRUMENTS AND DEVICES AND TECHNIQUE, INCLUDING TUBING SETS, CANNULA, SKIN PREPARATION, OPERATING ROOM CLEANLINESS, SURGICAL TECHNIQUE, AND THE PATIENT SKIN FLORA, IN ADDITION TO MANY OTHER FACTORS. BASED ON GID GROUP INVESTIGATION WHICH SHOWS NO INDICATION OF DEVICE MALFUNCTION, NO OTHER REPORTED INFECTIONS ASSOCIATED WITH THE REVOLVE LOT # 10208, AND THE NEGATIVE CULTURE REPORT, GID CONCLUDES THAT THERE IS A VERY HIGH PROBABILITY THAT THE REVOLVE DEVICE DID NOT CONTRIBUTE TO REPORTED STERILE ABSCESS. THERE ARE 100 UNITS IN LOT # 10208. SIXTY OF THE UNITS HAVE BEEN CONSUMED (USED). THERE ARE NO REPORTED INFECTIONS ASSOCIATED WITH ANY OF THE OTHER UNITS IN THE LOT. GID WILL CONTINUE TO MONITOR REVOLVE DEVICES FOR ANY ADDITIONAL REPORTS OF INFECTION. (B)(4).

    Description of Event or Problem · 1

    LIFECELL CORPORATION COMPLAINT (B)(4) DATED (B)(4) 2013 SUBMITTED TO GID GROUP INC (MANUFACTURER AND FILER OF THIS REPORT) NOTED "INFECTION" 2 WEEKS POST-OP WITH POTENTIAL FOR SERIOUS INJURY. PHYSICIAN DRAINED PUS FROM ABSCESS; ABSCESS CULTURE CAME BACK NEGATIVE, PATIENT HAD STERILE ABSCESS. GID CONVERSATION WITH PHYSICIAN - (B)(6): PATIENT PREVIOUSLY TREATED FOR LUMPECTOMY AT SITE OF ABSCESS, PROCEDURE WAS AUTOLOGOUS FAT TRANSFER REVISION TO RIGHT BREAST FOLLOWING LUMPECTOMY; PATIENT PLACED ON ANTIBIOTICS AFTER PHYSICIAN EXAMINED AND DRAINED ABSCESS; A SWAB OF ABSCESS FLUID SUBMITTED BY PHYSICIAN FOR CULTURE, RESULTS NEGATIVE; PATIENT IS DOING FINE, NOT SERIOUS OR LIFE-THREATENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351920 LIFECELL REVOLVE (OEM VERSION OF GID 700) SUCTION LIPOPLASTY SYSTEM - CODE MUU MUU THE GID GROUP INC. REVOLVE 10208

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other