BEUDAMED
    FDA Adverse Event Injury Summary report: Y

    INPLANT FUNNEL

    MDR report key: 11335345 · Received February 16, 2021

    Report

    Report Number
    3013980229-2021-70003
    Event Type
    Injury
    Date Received
    February 16, 2021
    Product Code
    KDD
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER HAS INDICATED THAT THE DEVICE WILL NOT BE RETURNED TO PROXIMATE CONCEPTS FOR ANALYSIS, AS THE DEVICE HAS BEEN DISCARDED. A MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED, AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE MRE VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATIONS AND PROCEDURES. AS SUCH, THIS COMPLAINT WILL BE CLOSED. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    DR. (B)(6) SUBMITTED A REPORT TO THE FDA (MW5098741) IN REGARDS TO AN ADVERSE EVENT DURING HIS OPERATION. DR. (B)(6) STATED IN HIS REPORT THAT A (B)(6) FEMALE WITH NO PRIOR MEDICAL HISTORY UNDERWENT A BREAST AUGMENTATION SURGERY, IN WHICH AN INPLANT FUNNEL (LOT 062320) WAS USED, ON (B)(6) 2020. DAYS AFTER THE SURGERY, THE PATIENT REPORTED A FEVER AND BEGAN BROAD-SPECTRUM ANTIBIOTICS SHORTLY AFTER. SHE RETURNED TO THE OPERATING ROOM IN 2021 AND DR. (B)(6) REPORTED THAT SHE EXPERIENCED DRAINAGE OF BROWN MURKY FLUID AROUND BOTH THE LEFT AND RIGHT BREAST IMPLANTS. BOTH IMPLANTS WERE REMOVED AND THE POCKETS WERE IRRIGATED AND CLOSED. PROXIMATE CONCEPTS FOLLOWED UP WITH DR. (B)(6) IN AN ATTEMPT TO GAIN MORE INFORMATION PERTAINING TO THE EVENT. DR. (B)(6) WAS ABLE TO PROVIDE THE LAB TESTS DONE ON THE PATIENT. THE CULTURE FAILED TO ISOLATE ANY AEROBIC ORGANISMS OR ANAEROBES, YIELDING A NEGATIVE RESULT. PROXIMATE CONCEPTS PERFORMED A MANUFACTURING RECORD EVALUATION (MRE), WHICH CONCLUDED THAT ALL INPLANT FUNNEL'S IN LOT 062320 WERE MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATIONS AND PROCEDURES. AS A RESULT OF PROXIMATE CONCEPTS' INVESTIGATION, THE CAUSE OF THE ADVERSE EVENT CANNOT BE TRACED BACK TO THE INPLANT FUNNEL. AS SUCH, THIS COMPLAINT WILL BE CLOSED. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232526 INPLANT FUNNEL KDD

    Patients

    Seq Age Sex Outcome Treatment
    1