BEUDAMED
    FDA Adverse Event Death Summary report: N

    AIGIS

    MDR report key: 7612041 · Received June 18, 2018

    Report

    Report Number
    2182208-2018-01145
    Event Type
    Death
    Date Received
    June 18, 2018
    Date of Event
    January 1, 2018
    Report Date
    February 18, 2019
    Manufacturer
    TYRX, INC.
    Product Code
    FTL
    PMA / PMN Number
    K130943
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. MULTIPLE PATIENTS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE DEVICE LOT NUMBERS. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: COST-EFFECTIVENESS OF TYRX ABSORBABLE ANTIBACTERIAL ENVELOPE FOR PREVENTION OF CARDIOVASCULAR IMPLANTABLE ELECTRONIC DEVICE INFECTION. JOURNAL OF MEDICAL ECONOMICS. 2018; 21(3):294-300. 10.1 080/13696998.2017.1409227. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    FOLLOW UP FROM THE CORRESPONDING AUTHOR INDICATED NONE OF THE MANUFACTURER PRODUCTS USED ARE RELATED TO ANY OF THE PATIENT DEATHS. NO ADDITIONAL INFORMATION WAS RECEIVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING ABSORBABLE ANTIBACTERIAL ENVELOPES. MULTIPLE PATIENTS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE DEVICE LOT NUMBERS. THE ARTICLE REPORTS THAT PATIENTS EXPERIENCED INFECTION. THE ARTICLE ADDITIONALLY REPORTS PATIENT HOSPITALIZATION AND PATIENT DEATHS AS A RESULT OF THE INFECTION. FURTHER FOLLOW UP DID NOT YET YIELD ANY ADDITIONAL INFORMATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452906 AIGIS MESH, SURGICAL, POLYMERIC FTL TYRX, INC. TYRX-AAE

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H| R