BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERI SURGICAL SCAFFOLD

    MDR report key: 6894035 · Received September 26, 2017

    Report

    Report Number
    3013417188-2017-00010
    Event Type
    Injury
    Date Received
    September 26, 2017
    Report Date
    August 16, 2017
    Manufacturer
    SOFREGEN MEDICAL, INC
    Product Code
    OXF
    PMA / PMN Number
    K123128
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON 07/18/2017, THE FOLLOWING INFORMATION WAS RECEIVED VIA EMAIL: "HAD AN EVENT WITH SERI AT 3 YEARS, BEING BALLED UP AND NEEDING TO BE REMOVED. IN MY LIMITED EXPERIENCE I HAVE NOT HEARD OF SUCH AN EVENT." NO ADDITIONAL INFORMATION WAS PROVIDED. ON 7/21/2017: DR. (B)(6) CALLED AND SUPPLIED ADDITIONAL INFORMATION. HE REPORTED THAT A PATIENT HAD COME IN 2 OR 3 YEARS AGO AND HER BREASTS HAD BOTTOMED OUT FROM A PREVIOUS AUGMENTATION. AT THIS TIME, HE IMPLANTED THE SERI SURGICAL MESH AT THE BASE OF THE BREASTS FOR EXTRA SUPPORT. THEN 2 OR 3 MONTHS AGO SHE CAME INTO THE OFFICE WITH A LUMP ON THE UNDERSIDE OF ONE BREAST. SHE WAS REFERRED TO A SURGEON WHO DECIDED TO REMOVE THE LUMP. THE LUMP WAS REMOVED, THERE WAS SCAR TISSUE SURROUNDING THE SERI MESH THAT WAS BALLED UP. THE SURGEON STATED THE PATIENT HAD A FOREIGN BODY REACTION. DR. ROSEN STATED HE HAS USED THE SERI WITH NO ISSUES IN THE PAST. HE WAS NOT IN THE OFFICE AND WAS UNABLE TO PROVIDE LOT NUMBER. HE WILL CHECK IN WITH HIS OFFICE NEXT WEEK AND CALL US BACK. ON 08/11/2017: SPOKE WITH THE PHYSICIAN AGAIN AND HE WAS UNABLE TO GIVE ANY ADDITIONAL INFORMATION. THE FACILITY WERE THE "BALLED UP SERI" WAS REMOVED WOULD NOT PROVIDE ANY ADDITIONAL INFORMATION TO DR. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674191 SERI SURGICAL SCAFFOLD SERI SURGICAL SCAFFOLD OXF SOFREGEN MEDICAL, INC UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention BREAST IMPLANTS-IMPLANT DATE OF 2-3 YEARS AGO