BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DULEX

    MDR report key: 9235188 · Received October 24, 2019

    Report

    Report Number
    1213643-2019-10221
    Event Type
    Injury
    Date Received
    October 24, 2019
    Report Date
    October 24, 2019
    Manufacturer
    BRIDGER BIOMED, INC. -3031159
    Product Code
    FTL
    PMA / PMN Number
    K003917
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME NO CONCLUSIONS CAN BE MADE TO WHAT EXTENT THE BARD/DAVOL DULEX (DEVICE #1) MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE ATTORNEY ALLEGES THAT THE PATIENT HAD INJURIES AND SUBSEQUENT SURGICAL INTERVENTION; HOWEVER, NO DETAILS HAVE BEEN PROVIDED. THE CAUSE OF THE PATIENT POSTOPERATIVE COMPLICATIONS CANNOT BE DETERMINED AT THIS TIME. NO LOT NUMBER HAS BEEN PROVIDED THEREFORE A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE PROVIDED A SUPPLEMENTAL EMDR WILL BE SUBMITTED. THIS EMDR REPRESENTS THE BARD/DAVOL DULEX (DEVICE #1). THERE IS NO ALLEGATION RELATED TO THE BARD/DAVOL VENTRIO ST. NOT RETURNED.

    Description of Event or Problem · 1

    ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRIO ST AND AN UNSPECIFIED BARD/DAVOL BARD DULEX (DEVICE #1) ON (B)(6) 2014. IT IS ALLEGED THAT THE PATIENT HAD UNSPECIFIED INJURIES AND SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE(S). AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE BARD/DAVOL BARD DULEX (DEVICE #1). AS REPORTED, THE ATTORNEY ALLEGES PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1027332 DULEX SURGICAL MESH FTL BRIDGER BIOMED, INC. -3031159 NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention