BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 133 TISSUE EXPANDER

    MDR report key: 14640199 · Received June 8, 2022

    Report

    Report Number
    9617229-2022-10323
    Event Type
    Injury
    Date Received
    June 8, 2022
    Date of Event
    August 20, 2021
    Report Date
    June 8, 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

    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. (B)(4). THE EVENTS OF NECROSIS, INFECTION (UNKNOWN ONSET), DELAYED HEALING AND ISCHEMIA 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 REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. REASON FOR REOPERATION: NECROSIS, INFECTION (UNKNOWN ONSET), DELAYED HEALING AND ISCHEMIA.

    Description of Event or Problem · 0

    THROUGH JOURNAL ARTICLE "PREVENTING INFECTION AFTER SYNTHETIC EXPANDER IMPLANTATION IN PATIENTS UNDERGOING BREAST RECONSTRUCTION" - 6 PATIENTS REPORTED SKIN ULCERS AT THE WOUND (ALL AFTER PRIMARY RECONSTRUCTION). ALL SIX ULCERS WERE DUE TO IMPAIRED BLOOD FLOW AT THE WOUND SITE. TWO OF THESE SIX PATIENTS UNDERWENT DEBRIDEMENT AND RESUTURING, TWO PATIENTS WERE SUCCESSFULLY TREATED WITH SHORT-TERM TOPICAL TREATMENT, AND THE REMAINING 2 PATIENTS REQUIRED MORE THAN A MONTH FOR THE WOUND TO STABILIZE. DURING THIS TIME PERIOD, INFECTION OCCURRED. 2 PATIENTS REPORTED ATOPIC DERMATITIS AND "6 PATIENTS REPORTED SKIN NECROSIS." THIS IS FOR AN UNKNOWN SIDE. DEVICE HAS BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630967 STYLE 133 TISSUE EXPANDER EXPANDER, SKIN, INFLATABLE LCJ ALLERGAN (COSTA RICA) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention