BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK INSPIRA GEL

    MDR report key: 13283133 · Received January 18, 2022

    Report

    Report Number
    9617229-2022-00211
    Event Type
    Injury
    Date Received
    January 18, 2022
    Date of Event
    December 16, 2021
    Report Date
    January 18, 2022
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT OF SEROMA 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: RUPTURE, SEROMA. ARTICLE CITATION: HAN, S.; KIM, R.; KIM, T.S.; PARK, J.H.; KIM, S.S.; JEONG, C.; LEE, J.H. A PRELIMINARY RETROSPECTIVE STUDY TO ASSESS THE SHORT-TERM SAFETY OF TRADITIONAL SMOOTH OR MICROTEXTURED SILICONE GEL-FILLED BREAST IMPLANTS IN KOREA. MEDICINA 16 DECEMBER 2021; 57, 1370. HTTPS://DOI.ORG/10.3390/MEDICINA57121370.

    Description of Event or Problem · 0

    THROUGH JOURNAL ARTICLE "A PRELIMINARY RETROSPECTIVE STUDY TO ASSESS THE SHORT-TERM SAFETY OF TRADITIONAL SMOOTH OR MICROTEXTURED SILICONE GEL-FILLED BREAST IMPLANTS IN KOREA" 8 PATIENTS WERE NOTED TO EXPERIENCE VARYING EVENTS INCLUDING "EARLY SEROMA" AND "RUPTURE." AFFECTED SIDES ARE UNKNOWN. DEVICE STATUS IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1035033 UNK INSPIRA GEL PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention