BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MCGHAN 168 ROUND TEXTURED SALINE IMPLANT

    MDR report key: 173905 · Received June 23, 1998

    Report

    Report Number
    173905
    Event Type
    Injury
    Date Received
    June 23, 1998
    Date of Event
    June 4, 1998
    Report Date
    June 22, 1998
    Manufacturer
    MCGHAN MEDICAL CORPORATION
    Product Code
    FWM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT HAD BILATERAL BREAST AUGMENTATION ON 8/24/1995. IMPLANTS RUPTURED AND REQUIRED REPLACEMENT ON 6/4/98. PT DISCHARGED ON 6/4/98.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MCGHAN 168 ROUND TEXTURED SALINE IMPLANT Implant SALINE BREAST IMPLANT FWM MCGHAN MEDICAL CORPORATION 27-168361 HE3703(LEFT); HE3772(RIGHT)

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention