BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK TISSUE EXPANDER

    MDR report key: 10986587 · Received December 10, 2020

    Report

    Report Number
    9617229-2020-20583
    Event Type
    Injury
    Date Received
    December 10, 2020
    Date of Event
    May 21, 2020
    Report Date
    December 10, 2020
    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 · 1

    ARTICLE CITATION: ¿RISK FACTORS FOR CAPSULAR CONTRACTURE: A RETROSPECTIVE STUDY IN IMMEDIATE RECONSTRUCTION VERSUS DELAYED RECONSTRUCTION;¿ MAIKO DE KERCKHOVE, MD, PHD, YOSHIKO IWAHIRA, MD, PHD; WOLTERS KLUWER HEALTH INC.; PRS GLOBAL OPEN 2020; 21 MAY 2020; THE AMERICAN SOCIETY OF PLASTIC SURGEONS 2020. (B)(4). THE EVENTS OF SEROMA, INFECTION (UNKNOWN ONSET), ISCHEMIA, WOUND DEHISCENCE, NECROSIS, EXPOSURE AND CAPSULAR CONTRACTURE 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: SEROMA, INFECTION (UNKNOWN ONSET), ISCHEMIA, WOUND DEHISCENCE, NECROSIS, EXPOSURE AND CAPSULAR CONTRACTURE GRADE III-IV.

    Description of Event or Problem · 1

    JOURNAL ARTICLE ¿RISK FACTORS FOR CAPSULAR CONTRACTURE: A RETROSPECTIVE STUDY IN IMMEDIATE RECONSTRUCTION VERSUS DELAYED RECONSTRUCTION¿ REPORTED COMPLICATIONS FOLLOWING DELAYED ¿EXPANDER INSERTION¿ OF ¿HEMATOMA, SEROMA, INFECTION, ISCHEMIC SKIN WOUND, EXPOSURE OCCURRENCE.¿ PATIENT WAS CONSIDERED TO EXPERIENCE HEMATOMA ¿IF HISTORY OF HEMATOMA REMOVAL OR A SUBCUTANEOUS HEMORRHAGE BEYOND THE DISSECTION AREA¿ AND SKIN ISCHEMIA ¿JUDGED TO BE PRESENT IN THE CASE OF NECROSIS OR DEHISCENCE OF THE WOUND MARGIN OR NIPPLE AREOLA REGIONS.¿ BAKER GRADE III OR IV WAS DIAGNOSED FOR ALL PATIENTS WITH CAPSULAR CONTRACTURE FORMATION. THE TISSUE EXPANDER WAS EXPLANTED AFTER 7 MONTHS. EVENTS OCCURRED ON AN UNKNOWN SIDE. THIS RECORD CAPTURES THE 27 PATIENTS WITH AN ALLERGAN EXPANDER WHERE SURGERY WAS DELAYED. THE EVENT OF HEMATOMA IS DEEMED TO BE NOT RELATED TO THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1448253 UNK TISSUE EXPANDER EXPANDER, SKIN, INFLATABLE LCJ ALLERGAN (COSTA RICA) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CHEMOTHERAPY, HORMONE THERAPY, AND RADIATION