BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK TISSUE EXPANDER

    MDR report key: 11126972 · Received January 6, 2021

    Report

    Report Number
    9617229-2020-22396
    Event Type
    Injury
    Date Received
    January 6, 2021
    Date of Event
    February 15, 2020
    Report Date
    January 6, 2021
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    LCJ
    PMA / PMN Number
    K862203
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ARTICLE CITATION: PREPECTORAL BREAST RECONSTRUCTION WITH TILOOP® BRA POCKET: A SINGLE CENTER PROSPECTIVE STUDY. F. LO TORTO, M. MARCASCIANO, J. KACIULYTE, U. REDI, L. BARELLINI, A. DE LUCA, A. PERRA, J. M. FRATTAROLI, E. CAVALIERI, G. DI TARANTO, M. GRECO AND D. CASELLA. EUROPEAN REVIEW FOR MEDICAL AND PHARMACOLOGICAL SCIENCES. FEB 2020; 24 (3): 991-999. 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: "SEROMA".

    Description of Event or Problem · 1

    LITERATURE REVIEW: "PREPECTORAL BREAST RECONSTRUCTION WITH TILOOP® BRA POCKET: A SINGLE CENTER PROSPECTIVE STUDY" REPORTED 2 PATIENTS EXPERIENCED A "SEROMA." TREATMENT WAS PROVIDED IN THE FORM OF ASPIRATIONS. SIDE UNKNOWN. DEVICE STATUS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20588 UNK TISSUE EXPANDER EXPANDER, SKIN, INFLATABLE LCJ ALLERGAN (COSTA RICA) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention