BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHASIX ST MESH

    MDR report key: 12612839 · Received October 12, 2021

    Report

    Report Number
    1213643-2021-08139
    Event Type
    Injury
    Date Received
    October 12, 2021
    Report Date
    October 12, 2021
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    OWT
    PMA / PMN Number
    K143380
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    NO CONCLUSIONS CAN BE MADE. THE PATIENT'S ATTORNEY ALLEGES "PAST, PRESENT, AND FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO, MENTAL AND PHYSICAL PAIN AND SUFFERING FOR SEVERE AND PERMANENT PERSONAL INJURIES SUSTAINED BY THE PATIENT"; HOWEVER, NO DETAILS HAVE BEEN PROVIDED. NO LOT NUMBER HAS BEEN PROVIDED; THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE. THIS EMDR REPRESENTS THE BARD/DAVOL PHASIX ST MESH (DEVICE #2). ADDITIONAL EMDRS WERE SUBMITTED TO REPRESENT THE BARD/DAVOL PHASIX ST MESH (DEVICE #1) AND THE BARD FLAT MESH (DEVICE #3). SHOULD ADDITIONAL INFORMATION BE PROVIDED, A SUPPLEMENTAL EMDR WILL BE SUBMITTED. NOT RETURNED.

    Description of Event or Problem · 1

    ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT MULTIPLE SURGICAL PROCEDURES FOR IMPLANT OF UNSPECIFIED BARD/DAVOL IMPLANTS; PHASIX ST (X3), ALLOMAX (X2) AND BARD MESH (BARD FLAT MESH). AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THREE OF THESE IMPLANTS, PHASIX ST (X2) AND BARD MESH (BARD FLAT MESH). DATES OF SURGICAL IMPLANT ARE IDENTIFIED (B)(6) 2015, (B)(6) 2017, (B)(6) 2018. THE DOCUMENT DOES NOT INCLUDE THE DATE OF IMPLANT FOR THE SPECIFIC DEVICES. ATTORNEY ALLEGES GENERAL ALLEGATIONS FOR ¿PAST, PRESENT, AND FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO, MENTAL AND PHYSICAL PAIN AND SUFFERING FOR SEVERE AND PERMANENT PERSONAL INJURIES SUSTAINED BY THE PATIENT." IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1517125 PHASIX ST MESH SURGICAL MESH OWT DAVOL INC., SUB. C.R. BARD, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability