BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MCGHAN ANATOMICAL STYLE "TEXTURED"SALINE BREAST IMPLANT 240CC

    MDR report key: 11207311 · Received January 20, 2021

    Report

    Report Number
    MW5098895
    Event Type
    Injury
    Date Received
    January 20, 2021
    Date of Event
    March 14, 2020
    Report Date
    January 18, 2021
    Manufacturer
    MOGHAN/ ALLERGAN
    Product Code
    FWM
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    INTRADUCTAL BREAST CANCER-RIGHT BREAST DIAGNOSED (B)(6) 1991; RIGHT MODIFIED RADICAL MASTECTOMY ON (B)(6) 1991. ON (B)(6) 1999 BREAST RECONSTRUCTION WITH PLACEMENT OF MCGHAN ANATOMICAL STYLE TEXTURED SALINE IMPLANT 240 CC BY DR. (B)(6) HOSPITAL ON (B)(6) 2020. (R) BREAST PAIN + SWELLING. ORIGINALLY THOUGHT FROM TRAUMA. SWELLING PROGRESSED + WAS SEEN BY DR. (B)(6) BWH PLASTIC SURGERY ON (B)(6) 2020. TELEMED VISIT ON (B)(6) 2020. ULTRASOUND RESULTS ¿ FLUID AROUND IMPLANT. DR. (B)(6), TELEMEDICINE ON (B)(6) 2020. DR. (B)(6) MRI SHOWN MODERATE PERI-IMPLANT EFFUSION. ON (B)(6) 2020 DR. (B)(6) HAD INDEPENDENT CONSULTATION WITH DR. (B)(6)-LYMPHOMA PROGRAM. WE WERE NEVER NOTIFIED BY THE HOSPITAL OR ALLERGAN ABOUT A RECALL. (B)(6) CANCER INSTITUTE. ON (B)(6) 2020 TELEVISIT DR. (B)(6)- IMPLANT NEEDED TO BE REMOVED. ¿CD3D¿ FROM SEROMA. ON (B)(6) 2020 INITIAL CONSULTATION DR. (B)(6) ¿ (B)(6) -LYMPHOMA PROGRAM- PET SCAN DONE EXCEPT FOR FLUID PERI IMPLANT (R) BREAST STAGE 1A BREAST IMPLANT ASSOCIATED ALCL NEG ANAPLASTIC LARGE CELL LYMPHOMA DIAGNOSIS. ® BREAST MARKEDLY SWOLLEN WITH PAIN, INCREASING PAIN + SWELLING. ON (B)(6) 2020 COMPLETE CAPSULECTOMY OF THE RIGHT BREAST WITH REMOVAL OF IMPLANT. DRISHED FROM OWLT (B)(6) 2020 WITH LARGE INCISION + JACKSON PRATT DRAIN. ON (B)(6) 2021 FOLLOW UP WITH (B)(6) ¿ WILL NEED SURVEILLANCE FOR TWO YEARS INCLUDING PET SCANS, OFFICE VISITS + LAB WORK EVERY SIX MONTHS. DEFINITIVE ¿DR¿ OF BIA ¿ ALCL- ALCL. FOLLOW UP ON (B)(6) 2021 DR. (B)(6) ¿ OFFICE VISIT TO CHECK INCISION + HEALING S/P BREAST IMPLANT REMOVAL. ¿ U-DEL¿ J.P. DRAIN REMOVAL + OFFICE VISIT WITH DR. (B)(6) POST OP VISIT. WILL RETURN ON (B)(6) 2021 FOR OFFICE VISIT CHECK INCISION. THIS FROM WAS FILLED OUT FOR MY MOTHER: (B)(6) BY HER DAUGHTER (B)(6) WHO HAS MEDICAL POWER OF ATTORNEY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101812 MCGHAN ANATOMICAL STYLE "TEXTURED"SALINE BREAST IMPLANT 240CC PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MOGHAN/ ALLERGAN UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| L| S