BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NO DEVICE

    MDR report key: 6073953 · Received November 2, 2016

    Report

    Report Number
    9617229-2016-00165
    Event Type
    Injury
    Date Received
    November 2, 2016
    Date of Event
    September 26, 2016
    Report Date
    December 5, 2016
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    LCJ
    PMA / PMN Number
    -
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OF INFECTION 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, AFFECTED SIDE, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. DEVICE LABELING: "DO NOT EXPOSE THE PRODUCT OR THE NEEDLE FOR PHYSIOLOGICAL SALINE INFUSION TO ANY CONTAMINATED OBJECT, IN VIEW OF POSSIBLE ELEVATION IN THE RISK FOR INFECTION." "IN PATIENTS HAVING ACTIVE INFECTION, IMPLANTATION OF THIS PRODUCT CAN ELEVATE THE RISK FOR INFECTION AROUND THE PRODUCT." "ALTHOUGH RARELY, ACUTE INFECTION MAY DEVELOP IN THE BREAST FOLLOWING INSERTION OF THE IMPLANT."

    Additional Manufacturer Narrative · 1

    EVENTS CONTAINED IN THIS MEDWATCH REPORT MFR # 9617229-2016-00165 IS DUPLICATE INFORMATION OF THE INFORMATION SENT IN MFR # 9617229-2016-00203.

    Description of Event or Problem · 1

    REPORTED EVENT OF A PATIENT EXPERIENCING A "MINOR INFECTION OF THE TE." THE EVENT WAS FOUND WITHIN THE ELECTRONIC JOURNAL ARTICLE, "AESTHETIC OUTCOMES OF INFRAMAMMARY FOLD RECREATION IN TWO-STAGE, IMPLANT-BASED, BREAST RECONSTRUCTION," IN SPRINGER OPEN, 16 SEPT. 2016, PP 1-6. THE AUTHORS STATED THAT ALL PATIENTS WERE IMPLANTED WITH ALLERGAN NATRELLE 133 TISSUE EXPANDERS THAT WERE REPLACED WITH ALLERGAN NATRELLE 410 DEVICES. IT IS UNKNOWN IF TREATMENT WAS PROVIDED. THE TISSUE EXPANDER WAS EXPLANTED AND REPLACED WITH A NATRELLE 410 DEVICE.

    Description of Event or Problem · 1

    DUPLICATE INFORMATION OF MFR # 9617229-2016-00203.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723122 NO DEVICE - LCJ ALLERGAN (COSTA RICA) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention