BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK MAMMARY IMPLANT

    MDR report key: 17568987 · Received August 17, 2023

    Report

    Report Number
    9617229-2023-13561
    Event Type
    Injury
    Date Received
    August 17, 2023
    Date of Event
    July 26, 2023
    Report Date
    August 17, 2023
    Manufacturer
    UNKNOWN MANUFACTURER
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONT. H.6: E1707 ROIDER, LAURA A., ET AL. ¿PRACTICE TRENDS IN THE MANAGEMENT OF ASYMPTOMATIC BREAST RECONSTRUCTION PATIENTS WITH TEXTURED IMPLANTS: A SURVEY ANALYSIS.¿ PLASTIC AND RECONSTRUCTIVE SURGERY - GLOBAL OPEN, VOL. 11, NO. 7, 2023, HTTPS://DOI.ORG/10.1097/GOX.0000000000005139. THE EVENTS OF "LYMPHOMA-ALCL, INFECTION, AND SEROMA" 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: LYMPHOMA-ALCL - SUSPECTED, INFECTION, AND SEROMA

    Description of Event or Problem · 0

    THROUGH THE JOURNAL ARTICLE ¿PRACTICE TRENDS IN THE MANAGEMENT OF ASYMPTOMATIC BREAST RECONSTRUCTION PATIENTS WITH TEXTURED IMPLANTS: A SURVEY ANALYSIS¿ REPORTED "SURGICAL SITE INFECTION, WOUND HEALING PROBLEMS, IMPLANT LOSS, HEMATOMA, AND SEROMA. AROUND 18% OF RESPONDENTS HAVE MANAGED A CASE OF BIA-ALCL." PATHOLOGICAL MARKERS WERE NOT GIVEN. THIS RECORD IS FOR AN UNKNOWN SIDE. DEVICE STATUS IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    851541 UNK MAMMARY IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM UNKNOWN MANUFACTURER NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention| L