BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK TISSUE EXPANDER

    MDR report key: 14573763 · Received June 2, 2022

    Report

    Report Number
    9617229-2022-10277
    Event Type
    Injury
    Date Received
    June 2, 2022
    Report Date
    June 7, 2022
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    LCJ
    PMA / PMN Number
    K862203
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    SATOKO ONISHI, MD, PHD, YOSHIKAZU INOUE, MD, PHD, MAKI INUKAI, MD, TAKAYUKI OKUMOTO, MD, PHD PREVENTING INFECTION AFTER SYNTHETIC EXPANDER IMPLANTATION IN PATIENTS UNDERGOING BREAST RECONSTRUCTION DEPARTMENT OF PLASTIC AND RECONSTRUCTIVE SURGERY 2021; 4 PAGES. THE EVENT OF INFECTION 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 (UNKNOWN ONSET).

    Additional Manufacturer Narrative · 0

    ARTICLE CITATION: SATOKO ONISHI, YOSHIKAZU INOUE, MAKI INUKAI, TAKAYUKI OKUMOTO, PREVENTING INFECTION AFTER SYNTHETIC EXPANDER IMPLANTATION IN PATIENTS UNDERGOING BREAST RECONSTRUCTION, FUJITA MEDICAL JOURNAL, 2022, VOLUME 8, ISSUE 2, PAGES 42-45, RELEASED ON J-STAGE MAY 01, 2022, ADVANCE ONLINE PUBLICATION AUGUST 20, 2021, ONLINE ISSN 2189-7255, PRINT ISSN 2189-7247, HTTPS://DOI.ORG/10.20407/FMJ.2020-029, HTTPS://WWW.JSTAGE.JST.GO.JP/ARTICLE/FMJ/8/2/8_2020-029/_ARTICLE/-CHAR/EN.

    Description of Event or Problem · 0

    THROUGH JOURNAL ARTICLE "PREVENTING INFECTION AFTER SYNTHETIC EXPANDER IMPLANTATION IN PATIENTS UNDERGOING BREAST RECONSTRUCTION" 1(ONE) PATIENT REPORTED "INFECTION HAD POORLY CONTROLLED ATOPIC DERMATITIS" AS WELL AS "INFLAMMATORY SYMPTOMS, INCLUDING ERYTHEMA AND SWELLING AT THE WOUND SITE, FEVER" AND (B)(6). THIS IS FOR AN UNKNOWN SIDE. DEVICE HAS BEEN EXPLANTED.

    Description of Event or Problem · 0

    THROUGH JOURNAL ARTICLE "PREVENTING INFECTION AFTER SYNTHETIC EXPANDER IMPLANTATION IN PATIENTS UNDERGOING BREAST RECONSTRUCTION" 1(ONE) PATIENT REPORTED "INFECTION HAD POORLY CONTROLLED ATOPIC DERMATITIS" AS WELL AS "INFLAMMATORY SYMPTOMS, INCLUDING ERYTHEMA AND SWELLING AT THE WOUND SITE, FEVER" AND "METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS (MRSA)." THIS IS FOR AN UNKNOWN SIDE. DEVICE HAS BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2161171 UNK TISSUE EXPANDER EXPANDER, SKIN, INFLATABLE LCJ ALLERGAN (COSTA RICA) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention