BEUDAMED
    FDA Adverse Event Injury Summary report: Y

    LATERA ABSORBABLE NASAL 2 IMPLANTS GEN 1

    MDR report key: 11878038 · Received May 25, 2021

    Report

    Report Number
    3006345872-2021-00005
    Event Type
    Injury
    Date Received
    May 25, 2021
    Date of Event
    April 8, 2021
    Report Date
    August 30, 2021
    Manufacturer
    ENTELLUS MEDICAL, INC.
    Product Code
    NHB
    PMA / PMN Number
    K161191
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED ON MAY 13, 2021 INDICATES A BILATERAL REMOVAL WAS PERFORMED ON (B)(6) 2021. A PATHOLOGY REPORT WAS SUBMITTED THAT NOTES A PATHOLOGIC DIAGNOSIS OF NASAL SIDE WALLS LEFT AND RIGHT BIOPSY FOUND BENIGN SKIN WITH FRAGMENTS OF FIBROUS TISSUE AND NON-POLARIZABLE FOREIGN MATERIAL ASSOCIATED WITH GRANULOMATOUS/FOREIGN BODY GIANT CELL REACTION. THE IMPLANT WAS NOT RETURNED TO ENTELLUS MEDICAL FOR TESTING. THE PATHOLOGY TESTING WAS PERFORMED IN THE FIELD BY THE HOSPITAL.

    Description of Event or Problem · 0

    IT WAS REPORTED THE LATERA IMPLANTS WERE BILATERALLY PLACED ON (B)(6) 2018 DURING A SEPTOPLASTY AND TURBINATE REDUCTION PROCEDURE. ON (B)(6) 2021 THE PATIENT REPORTED BILATERAL IMPLANTS ARE VISIBLE AND MIGRATING TOWARD SKIN SURFACE AND APPEAR TO BE STARTING TO EXTRUDE THROUGH THE SKIN. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2021 INDICATES A BILATERAL REMOVAL WAS PERFORMED ON (B)(6) 2021. A PATHOLOGY REPORT WAS SUBMITTED THAT NOTES A PATHOLOGIC DIAGNOSIS OF NASAL SIDE WALLS LEFT AND RIGHT BIOPSY FOUND BENIGN SKIN WITH FRAGMENTS OF FIBROUS TISSUE AND NON-POLARIZABLE FOREIGN MATERIAL ASSOCIATED WITH GRANULOMATOUS/FOREIGN BODY GIANT CELL REACTION.

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THE LATERA IMPLANTS WERE BILATERALLY PLACED ON (B)(6) 2018 DURING A SEPTOPLASTY AND TURBINATE REDUCTION PROCEDURE. ON (B)(6) 2021 THE PATIENT REPORTED BILATERAL IMPLANTS ARE VISIBLE AND MIGRATING TOWARD SKIN SURFACE AND APPEAR TO BE STARTING TO EXTRUDE THROUGH THE SKIN. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2021 INDICATES A BILATERAL REMOVAL WAS PERFORMED ON (B)(6) 2021. A PATHOLOGY REPORT WAS SUBMITTED THAT NOTES A PATHOLOGIC DIAGNOSIS OF NASAL SIDE WALLS LEFT AND RIGHT BIOPSY FOUND BENIGN SKIN WITH FRAGMENTS OF FIBROUS TISSUE AND NON-POLARIZABLE FOREIGN MATERIAL ASSOCIATED WITH GRANULOMATOUS/FOREIGN BODY GIANT CELL REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    774334 LATERA ABSORBABLE NASAL 2 IMPLANTS GEN 1 NHB, LATERA ABSORBABLE NASAL NHB ENTELLUS MEDICAL, INC. 204641

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R