BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 1210483 · Received October 22, 2008

    Report

    Report Number
    1210483
    Event Type
    Injury
    Date Received
    October 22, 2008
    Date of Event
    October 17, 2008
    Report Date
    October 22, 2008
    Manufacturer
    UNK
    Product Code
    FTR
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT BILATERAL BREAST AUGMENTATION IN 1981. IN 2008, THE PT SUSTAINED DIRECT TRAUMA TO HER CHEST AREA WITH PAIN. PER HER HISTORY AND PHYSICAL, AN MRI WAS SUGGESTIVE OF SILICONE IMPLANT RUPTURE OF THE LEFT BREAST. PT PRESENTED TO THE OR AT ABOUT FIVE MONTHS LATER FOR BILATERAL EXPLANTATION OF BREAST IMPLANTS, WITH REINSERTION OF NEW IMPLANTS. PRE OP DIAGNOSIS: RUPTURED BREAST IMPLANT. SURGICAL PROCEDURE: EXPLANTATION RUPTURED SILICONE IMPLANTS, BILATERAL RADICAL CAPSULECTOMIES WITH BREAST AUGMENTATION WITH SALINE IMPLANTS.

    Description of Event or Problem · 2

    PT UNDERWENT BILATERAL BREAST AUGMENTATION IN 1981. IN '08, THE PT SUSTAINED DIRECT TRAUMA TO HER CHEST AREA WITH PAIN. PER HER HISTORY AND PHYSICAL, AN MRI WAS SUGGESTIVE OF SILICONE IMPLANT RUPTURE OF THE LEFT BREAST. PT PRESENTED TO THE OR AT ABOUT FIVE MONTHS LATER FOR BILATERAL EXPLANTATION OF BREAST IMPLANTS, WITH REINSERTION OF NEW IMPLANTS. PRE OP DIAGNOSIS: RUPTURED BREAST IMPLANT. SURGICAL PROCEDURE: EXPLANTATION RUPTURED SILICONE IMPLANTS, BILATERAL RADICAL CAPSULECTOMIES WITH BREAST AUGMENTATION WITH SALINE IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK SILICONE MAMMARY PROSTHESIS (RIGHT) FTR UNK UNK UNK
    2 UNK SILICONE MAMMARY PROSTHESIS (LEFT) FTR UNK UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention
    2 56 YR