BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK TISSUE EXPANDER

    MDR report key: 11265139 · Received February 2, 2021

    Report

    Report Number
    9617229-2021-00563
    Event Type
    Injury
    Date Received
    February 2, 2021
    Date of Event
    November 7, 2020
    Report Date
    February 2, 2021
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    LCJ
    PMA / PMN Number
    K862203
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OF INFECTION (EARLY ONSET) IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. REASON FOR REOPERATION: INFECTION (EARLY ONSET).

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED FOR RIGHT SIDE "RED BREAST SYNDROME WITH ALLODERM", "SKIN IS VERY RED DIRECTLY OVER THE AREA WHERE THE ALLODERM IS PRESENT". "PATIENT DESCRIBED A 2 DAY COURSE OF REDNESS TO THE R BREAST WITH A FEELING OF CHILLS. AT THE TIME OF ADMISSION ENTIRE RIGHT BREAST WAS RED, BUT THE ERYTHEMA STOPPED EXACTLY AT THE EDGE OF THE ALLODERM. AN U/S WAS PERFORMED AND NO SEROMA WAS IDENTIFIED. CRP AND WBC WERE NORMAL AND WAS NOT FEBRILE WHILE IN THE HOSPITAL. TREATED WITH ANCEF AND KEPT IN HOSPITAL FOR 4 DAYS. LOOKED BETTER IN THE MORNING AND THEN BECOME MORE RED OVER THE DAY. PATIENT WAS DISCHARGED AND PRESCRIBED KEFLEX AND CELEBREX WITH A PRESUMED DX OF RED BREAST SYNDROME. ON (B)(6), PATIENT WAS SEEN IN FOLLOWUP AND NOTED TO HAVE IMPROVED REDNESS TO THE SUPERIOR BREAST BUT A PROGRESSIVE PURPLE DISCOLORATION OF THE INFERIOR BREAST. PHYSICIAN REMOVED 30CC OF FILL FROM THE EXPANDER. NEXT DAY, SPONTANEOUS DRAIN TURBID FLUID FROM INCISION. THE EXPANDER AND MAJORITY OF THE ALLODERM WAS REMOVED. IT WAS SENT FOR CULTURE AND GREW MODERATE GROWTH OF ACINETOBACTER SPECIES. SINCE THEN, SYMPTOMS HAVE RESOLVED. THE DEVICE HAS BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164725 UNK TISSUE EXPANDER EXPANDER, SKIN, INFLATABLE LCJ ALLERGAN (COSTA RICA) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention