BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 7812 · Received February 4, 1994

    Report

    Report Number
    7812
    Event Type
    Injury
    Date Received
    February 4, 1994
    Date of Event
    October 5, 1992
    Manufacturer
    BAXTER HEALTHCARE CORP. (HEYER-SCHULTE)
    Product Code
    FTR
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    THE PATIENT IN MARCH, 1975 HAD PLACED SILICONE BREAST IMPLANTS FOR BREAST AUGMENTATION. SHE HAS A HISTORY OF FATIGUE, LEFT KNEE AND HIP PAIN, AND MULTIPLE BACK PROBLEMS INCLUDING A SPINAL FUSION. THE PATIENT HAD A BILATERAL PERIPROSTHETIC CAPSULECTOMY WITH REMOVAL OF THE IMPLANTS. THE RIGHT IMPLANT WAS STICKY AND THE LEFT IMPLANT HAD A FRANK RUPTURE.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: VISUAL EXAMINATION, OTHER. RESULTS OF EVALUATION: UNANTICIPATED, INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: OTHER. THE DEVICE WAS DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN Implant HEYER-SCHULTE LOW PROFILE SILICONE GEL IMPLANT-185CC FTR BAXTER HEALTHCARE CORP. (HEYER-SCHULTE) UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other