BEUDAMED
    FDA Adverse Event Injury Summary report: N

    168-240

    MDR report key: 1101797 · Received August 6, 2008

    Report

    Report Number
    2024601-2008-00410
    Event Type
    Injury
    Date Received
    August 6, 2008
    Date of Event
    June 10, 2008
    Report Date
    July 8, 2008
    Manufacturer
    SANTA BARBARA
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDWATCH SENT TO FDA ON 08/06/08. THE REPORTER OF THE COMPLAINT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS BUT THE MAMMARY IMPLANT WAS DISCARDED AFTER SURGERY. DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF INFLATION AS FOLLOWS: "IF ANY UNUSUAL SYMPTOMS OCCUR AFTER SURGERY, SUCH AS FEVER OR NOTICEABLE SWELLING OR REDNESS IN ONE BREAST, YOU SHOULD CONTACT YOUR SURGEON IMMEDIATELY." DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOMES OF IRRITATION/INFLAMMATION AS FOLLOWS: "POSTOPERATIVE HEMATOMA AND SEROMA MAY CONTRIBUTE TO INFECTION AND/OR CAPSULAR CONTRACTURE. SWELLING, PAIN, AND BRUISING MAY RESULT. IF A HEMATOMA OCCURS, IT WILL USUALLY TO BE SOON AFTER SURGERY, HOWEVER, THIS CAN ALSO OCCUR AT ANY TIME AFTER INJURY TO THE BREAST. WHILE THE BODY ABSORBS SMALL HEMATOMAS AND SEROMAS, LARGE ONES WILL REQUIRE THE PLACEMENT OF SURGICAL DRAINS FOR PROPER HEALING." "THE FOLLOWING IS A LIST OF POTENTIAL ADVERSE EVENTS MAY OCCUR WITH BREAST IMPLANT SURGERY. SOME OF THESE ADVERSE EVENTS HAVE BEEN REPORTED IN TABLES 1 AND 2 A ABOVE. THE RISKS INCLUDE: IMPLANT DEFLATION/LEAKAGE, ADDITIONAL SURGERY, CAPSULAR CONTRACTURE, INFECTION, TOXIC SHOCK SYNDROME, NECROSIS, HEMATOMA, SEROMA, EXTRUSION, BREAST PAIN, CHANGES IN NIPPLE SENSATION, CHANGES IN BREAST SENSATION, DISSATISFACTION WITH COSMETIC RESULTS (WRINKLING, FOLDING, DISPLACEMENT, ASYMMETRY, PALPABILITY, VISIBILITY, PTOSIS, SLOSHING), CALCIFIC DEPOSITS, IRRITATION/INFLAMMATION, DELAYED WOUND HEALING, HYPERTROPHIC SCARRING, BREAST TISSUE ATROPHY/CHEST WALL DEFORMITY, DIFFICULTY/INABILITY IN BREAST FEEDING, AND INABILITY TO ADEQUATELY VISUALIZE BREAST LESIONS WITH MAMMOGRAPHY."

    Description of Event or Problem · 1

    LEFT SIDE DEFLATION, PATIENT FELL IN BATHTUB. FOLLOW UP FINDINGS: DEVICE NOT DEFLATED, INFLATION; DEVICE RELATED PER PHYSICIAN. NO RELATIONSHIP TO PREVIOUSLY REPORTED FALL. FOLLOW-UP FINDINGS: FALL WAS AGAINST THE BATHTUB, AND WITHIN 10 DAYS THE SITE WAS WARM AND 1 1/2 TIMES LARGER. PHYSICIAN INITIALLY SUSPECTED BLEEDING, BUT BELIEVED DEVICE TRIED TO EQUALIZE ITSELF AND THOUGH IT FILLED. NO SIGN OF INFECTION. TREATED WITH REMOVAL OF IMPLANTS BILATERALLY, CAPSULECTOMY SIZE EXCHANGE AND REPLACEMENT WITH SILICONE GEL IMPLANTS. EXPLANTED DEVICES DESTROYED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 168-240 SALINE BREAST IMPLANT FWM SANTA BARBARA STYLE 168 598610

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention