BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHASIX ST MESH

    MDR report key: 12070453 · Received June 25, 2021

    Report

    Report Number
    1213643-2021-20167
    Event Type
    Injury
    Date Received
    June 25, 2021
    Date of Event
    January 1, 2021
    Report Date
    June 7, 2021
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC. -1213643
    Product Code
    OWT
    PMA / PMN Number
    K143380
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS REPORTED, A PHASIX ST MESH WAS IMPLANTED INTO A CONTAMINATED FIELD. POST IMPLANT, THE PATIENT EXPERIENCED INFECTION WITH CHRONIC SINUSES. THE WARNING SECTION OF THE INSTRUCTIONS-FOR-USE SUPPLIED WITH STATES, ¿THE USE OF ANY SYNTHETIC MESH OR PATCH IN A CONTAMINATED OR INFECTED WOUND COULD LEAD TO FISTULA FORMATION AND/OR EXTRUSION OF THE MESH AND IT IS NOT RECOMMENDED¿; ALSO STATED IS "IF AN INFECTION DEVELOPS, TREAT THE INFECTION AGGRESSIVELY. CONSIDERATION SHOULD BE GIVEN REGARDING THE NEED TO REMOVE THE MESH. AN UNRESOLVED INFECTION MAY REQUIRE REMOVAL OF THE DEVICE." NO LOT NUMBER HAS BEEN PROVIDED; THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE. BASED ON THE AVAILABLE INFORMATION, A DEFINITIVE ROOT CAUSE IS NOT DETERMINED, HOWEVER, THE REPORTED EVENT IS A KNOWN POTENTIAL COMPLICATION OF SYNTHETIC MESH BEING IMPLANTED INTO A CONTAMINATED WOUND. NOTE, THE DATE OF EVENT AND IMPLANT IS CONSIDERED TO BE A BEST ESTIMATE AS (B)(6) 2021. SHOULD ADDITIONAL INFORMATION BE PROVIDED, A SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    AS REPORTED, A PATIENT UNDERWENT INTRAPERITONEAL IMPLANT OF A BARD/DAVOL PHASIX ST MESH. THE MESH WAS PLACED IN A CONTAMINATED FIELD. POSTOPERATIVELY, THE PATIENT DEVELOPED AN INFECTION WITH CHRONIC SINUSES. PATIENT IS APPROXIMATELY SIX MONTHS POSTOPERATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    967025 PHASIX ST MESH SURGICAL MESH OWT DAVOL INC., SUB. C.R. BARD, INC. -1213643 NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention