BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK MAMMARY IMPLANT

    MDR report key: 13315177 · Received January 21, 2022

    Report

    Report Number
    9617229-2022-01006
    Event Type
    Injury
    Date Received
    January 21, 2022
    Date of Event
    September 29, 2020
    Report Date
    January 21, 2022
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). ARTICLE CITATION: CJIM THUENISSEN, RM BROHET, Y HU, JH VAN UCHELEN, JHC MENSEN, AL VAN RIJSSENV, "RISK OF BREAST IMPLANT REMOVAL AFTER ONE VERSUS TWO-STAGE BREAST RECONSTRUCTIVE SURGERY" , JOURNAL OF PLASTIC, RECONSTRUCTIVE & AESTHETIC SURGERY, HTTPS://DOI.ORG/10.1016/J.BJPS.2021.11.112, 30-DEC-2021. THE EVENTS OF SEROMA, INFECTION, NECROSIS AND WOUND DEHISSENCE 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: "INFECTION" , "NECROSIS OF SKIN OR NIPPLE, BLEEDING" , "TISSUE EXPANDER/IMPLANT DEFLATION OR RUPTURE ","SEROMA", "SECONDARY CORRECTIONS OF ONE OF THE BREASTS TO IMPROVE COSMETIC RESULTS WITHIN THE FIRST YEAR AFTER BREAST RECONSTRUCTION, WOUND DEHISCENCE" AND "POSITIVE TUMOR MARGINS AFTER MASTECTOMY (REQUIRING REOPERATION)".

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED THROUGH JOURNAL ARTICLE THAT PATIENTS EXPERIENCED "INFECTION" , "NECROSIS OF SKIN OR NIPPLE, BLEEDING" , "TISSUE EXPANDER/IMPLANT DEFLATION OR RUPTURE ","SEROMA", "SECONDARY CORRECTIONS OF ONE OF THE BREASTS TO IMPROVE COSMETIC RESULTS WITHIN THE FIRST YEAR AFTER BREAST RECONSTRUCTION, WOUND DEHISCENCE" AND "POSITIVE TUMOR MARGINS AFTER MASTECTOMY (REQUIRING REOPERATION)" ON UNSPECIFIED SIDES. THE EVENT OF " POSITIVE TUMOUR MARGINS AFTER MASTECTOMY (REQUIRING REOPERATION)" IS NOT CONSIDERED DEVICE RELATED. THE DEVICE STATUSES ARE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    858838 UNK MAMMARY IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention