BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK KELLER FUNNEL2

    MDR report key: 19601091 · Received June 24, 2024

    Report

    Report Number
    3011299751-2024-00097
    Event Type
    Injury
    Date Received
    June 24, 2024
    Date of Event
    May 12, 2024
    Report Date
    June 24, 2024
    Manufacturer
    ALLERGAN (KELLER)
    Product Code
    KDD
    PMA / PMN Number
    510(K)EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENTS OF INFECTION AND WOUND DEHISCENCE ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN/WILL BE REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE REASON FOR REOPERATION IS: "MINOR INFECTION AT THE INCISION SITES AND SUBSEQUENT WOUND DEHISCENCE." ARTICLE CITATION: ELSAFTAWY, AHMED, ET AL. "ENHANCING BUTTOCK CONTOURS: A SAFER APPROACH TO GLUTEAL AUGMENTATION WITH ULTRASONIC LIPOSUCTION, SUBMUSCULAR IMPLANTS, AND ULTRASOUND-GUIDED FAT GRAFTING." J. CLIN. MED. 2024, 13, 2856. HTTPS://DOI.ORG/10.3390/JCM13102856.

    Description of Event or Problem · 0

    THROUGH JOURNAL ARTICLE "ENHANCING BUTTOCK CONTOURS: A SAFER APPROACH TO GLUTEAL AUGMENTATION WITH ULTRASONIC LIPOSUCTION, SUBMUSCULAR IMPLANTS, AND ULTRASOUND-GUIDED FAT GRAFTING" PATIENT EXPERIENCED A "MINOR INFECTION AT THE INCISION SITES AND SUBSEQUENT WOUND DEHISCENCE." THE SURGICAL PROCEDURE UTILIZED A KELLER-FUNNEL 2 DEVICE. ULTRASOUND-ASSISTED LIPOSUCTION AND ULTRASOUND-GUIDED FAT GRAFTING WERE PERFORMED. TREATMENT INCLUDED ULTRASONIC LIPOSUCTION USING A VASER DEVICE. PAIN MANAGEMENT MEDICATION WAS ADMINISTERED AS PART OF TREATMENT ALONG WITH LYMPHATIC MASSAGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2101988 UNK KELLER FUNNEL2 KIT, SURGICAL INSTRUMENT, DISPOSABLE KDD ALLERGAN (KELLER) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Female Required Intervention