BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK GEL BREAST IMPLANT

    MDR report key: 19620287 · Received June 26, 2024

    Report

    Report Number
    9617229-2024-15794
    Event Type
    Injury
    Date Received
    June 26, 2024
    Date of Event
    April 28, 2024
    Report Date
    June 26, 2024
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    JOURNAL ARTICLE CITATION: NICOLE SANCHEZ FIGUEROA, DOGA KURUOGLU, VAHE FAHRADYAN, NHO TRAN, BASEL SHARAF, JORYS MARTÍNEZ-JORGE, FEMINIZING GENDER AFFIRMING BREAST SURGERY: PROCEDURAL OUTCOMES AT A SINGLE ACADEMIC INSTITUTION, AESTHETIC SURGERY JOURNAL OPEN FORUM, VOLUME 6, 2024, OJAE032, HTTPS://DOI.ORG/10.1093/ASJOF/OJAE032. THE EVENT OF WOUND DEHISCENCE AND INFECTION (UNKNOWN ONSET) 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. THE REASON FOR REOPERATION: WOUND DEHISCENCE, INFECTION; DEVICE REMAINS IMPLANTED PER ARTICLE.

    Description of Event or Problem · 0

    LITERATURE ARTICLE: "FEMINIZING GENDER AFFIRMING BREAST SURGERY: PROCEDURAL OUTCOMES AT A SINGLE ACADEMIC INSTITUTION." IN ARTICLE REPORTED MINOR COMPLICATION "SURGICAL SITE INFECTION, FULL THICKNESS WOUND DEHISCENCE."THE DEVICE REMAINS IMPLANTED. EVENTS WERE TREATED, NO SURGERY FOR REPLACEMENT PER ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479924 UNK GEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention