BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK TISSUE EXPANDER

    MDR report key: 14605515 · Received June 6, 2022

    Report

    Report Number
    9617229-2022-10279
    Event Type
    Injury
    Date Received
    June 6, 2022
    Report Date
    June 6, 2022
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    LCJ
    PMA / PMN Number
    K862203
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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. 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.

    Description of Event or Problem · 0

    THROUGH JOURNAL ARTICLE "PREVENTING INFECTION AFTER SYNTHETIC EXPANDER IMPLANTATION IN PATIENTS UNDERGOING BREAST RECONSTRUCTION" IT WAS REPORTED PATIENT "WITH AN INFECTION HAD A SKIN ULCER AT THE POSTOPERATIVE WOUND SITE. IT WAS TREATED CONSERVATIVELY WITH OINTMENT, AND THE WOUND STABILIZED. CHEMOTHERAPY WAS STARTED 1 MONTH POSTOPERATIVELY, AFTER WHICH INFLAMMATORY FINDINGS, INCLUDING CHEST ERYTHEMA, AND FEVER WERE OBSERVED. TREATMENT WITH INTRAVENOUS ANTIBIOTICS WAS UNSUCCESSFUL, AND THE IMPLANT WAS REMOVED. (B)(6) WAS ISOLATED FROM CULTURES OF THE WOUND SITE SPECIMEN THAT HAD BEEN COLLECTED INTRAOPERATIVELY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215279 UNK TISSUE EXPANDER EXPANDER, SKIN, INFLATABLE LCJ ALLERGAN (COSTA RICA) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention