BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORTIVA PORCINE DERMIS

    MDR report key: 12125514 · Received July 6, 2021

    Report

    Report Number
    3002924436-2021-00017
    Event Type
    Injury
    Date Received
    July 6, 2021
    Date of Event
    April 1, 2020
    Report Date
    January 4, 2022
    Manufacturer
    TUTOGEN MEDICAL GMBH
    Product Code
    FTM
    PMA / PMN Number
    K142070
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    RTI RECEIVED UPDATED INFORMATION THAT STATED SERIAL ID (B)(6), THAT WAS INITIALLY REPORTED AS BEING IMPLANTED, WAS DOCUMENTED IN ERROR. ONLY ONE FORTIVA GRAFT WITH THE SERIAL ID (B)(6) WAS IMPLANTED (MED WATCH REPORT 3002924436-2021-00018).

    Additional Manufacturer Narrative · 1

    THE GRAFTS REMAIN IMPLANTED. THEREFORE, OUR INVESTIGATION IS BASED ON A COMPREHENSIVE RECORDS RE-REVIEW. ONCE THE INVESTIGATION IS COMPLETED AND RESULTS AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    RTI SURGICAL, INC (RTI) AND TUTOGEN MEDICAL GMBH (TMI), A WHOLLY OWNED SUBSIDIARY OF RTI, RECEIVED A COMPLAINT AS PART OF THE FORTIVA APPEAR TRIAL. THE REPORTED COMPLAINT INDICATED THAT A PATIENT WITH HISTORY OF STAGE 0 BREAST CANCER UNDERWENT A NIPPLE REMOVING, SKIN SPARING MASTECTOMY WITH BREAST RECONSTRUCTION. TWO FORTIVA PORCINE DERMIS GRAFTS WERE IMPLANTED ON (B)(6) 2020 (SERIAL IDS (B)(4) ON THE LEFT SIDE AND (B)(4) ON THE RIGHT SIDE). THIS REPORT PERTAINS TO SERIAL ID (B)(4). ON (B)(6) 2020 THE PATIENT DEVELOPED PAIN AND SEROMA FORMATION. THE INFORMATION PROVIDED INDICATED THAT A 200ML AND AN 80ML SEROMA WERE DRAINED. IT IS UNKNOWN AT THIS TIME IF THE PATIENT DEVELOPED THE SEROMAS IN ONE BREAST OR BILATERALLY. THE SEROMAS RESOLVED AFTER DRAINAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1021096 FORTIVA PORCINE DERMIS SURGICAL MESH FTM TUTOGEN MEDICAL GMBH PD18480001

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Female Other