BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH - VENTRALEX

    MDR report key: 7803237 · Received August 21, 2018

    Report

    Report Number
    1213643-2018-02852
    Event Type
    Injury
    Date Received
    August 21, 2018
    Date of Event
    March 24, 2016
    Report Date
    September 30, 2025
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC. -1213643
    Product Code
    FTL
    PMA / PMN Number
    K132441
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THERE IS NO CONNECTION THAT CAN BE MADE AT THIS TIME BETWEEN THE REPORTED UNSPECIFIED POST-OPERATIVE COMPLICATIONS AND ANY PROBLEM WITH THE BARD/DAVOL VENTRALEX (DEVICE #2) USED TO TREAT THE PATIENT. THE PATIENT'S ATTORNEY DID NOT ALLEGE A SPECIFIC DEVICE FAILURE OR PATIENT ADVERSE EVENT, AND NO MEDICAL RECORDS HAVE BEEN PROVIDED. BASED ON THE LIMITED INFORMATION PROVIDED AT THIS TIME, NO CONCLUSIONS CAN BE MADE. NO LOT NUMBER HAS BEEN PROVIDED; THEREFORE A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE AT THIS TIME. ADDENDUM: THIS SUPPLEMENTAL EMDR IS SUBMITTED TO DOCUMENT ADDITIONAL INFORMATION PROVIDED. ROOT CAUSE IS INCONCLUSIVE, NO CONCLUSION CAN BE MADE AS TO THE EXTENT TO WHICH THE IMPLANT MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S POSTOPERATIVE COURSE. NOTE, THE MANUFACTURING DATE (15-JUL-2015) IS CONSIDERED TO BE A BEST ESTIMATE. THIS SUPPLEMENTAL EMDR REPRESENTS THE BARD/DAVOL - VENTRALEX MESH (DEVICE 2). AN ADDITIONAL SUPPLEMENTAL EMDR WAS SUBMITTED TO REPRESENT THE BARD/DAVOL - 3DMAX MESH (DEVICE 1). NOTE: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

    Description of Event or Problem · 0

    THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: (B)(6) 2015: THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL 3DMAX (DEVICE #1) AND A BARD/DAVOL VENTRALEX (DEVICE #2). THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE 3DMAX (DEVICE #1) AND THE VENTRALEX (DEVICE #2). THE PATIENT'S 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.¿ ADDENDUM PER ADDITIONAL INFORMATION PROVIDED: (B)(6) 2015 ¿ PATIENT WAS DIAGNOSED WITH RIGHT INGUINAL HERNIA AND UMBILICAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC AND OPEN REPAIR WITH IMPLANT OF 3DMAX MESH AND VENTRALEX MESH. PER OPERATIVE NOTES, ¿INDIRECT RIGHT INGUINAL HERNIA WAS REDUCED AND 3DMAX MESH (DEVICE 1) WAS PLACED COVERING THE INGUINAL DEFECT AND SUTURED. THE UMBILICAL HERNIA IN ANTERIOR ABDOMINAL WALL WAS REDUCED AND SMALL SIZE VENTRALEX MESH (DEVICE 2) WAS PLACED AND SECURED WITH SUTURES.¿ (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH PERSISTENT NONHEALING UMBILICAL SKIN SINUS THEREBY UNDERWENT OPEN REPAIR WITH EXCISION AND DEBRIDEMENT OF UMBILICAL SKIN SINUS. PER OPERATIVE NOTES, ¿DRAINAGE FROM THE UMBILICUS WAS NOTED AND DRAINED. SINUS TRACT FROM ABDOMINAL WALL WAS RESECTED. (NOTE: THE UMBILICAL MESH (DEVICE 2) WAS NOT SEEN DURING THIS PROCEDURE.)

    Additional Manufacturer Narrative · 1

    THERE IS NO CONNECTION THAT CAN BE MADE AT THIS TIME BETWEEN THE REPORTED UNSPECIFIED POST-OPERATIVE COMPLICATIONS AND ANY PROBLEM WITH THE BARD/DAVOL VENTRALEX (DEVICE #2) USED TO TREAT THE PATIENT. THE PATIENT'S ATTORNEY DID NOT ALLEGE A SPECIFIC DEVICE FAILURE OR PATIENT ADVERSE EVENT, AND NO MEDICAL RECORDS HAVE BEEN PROVIDED. BASED ON THE LIMITED INFORMATION PROVIDED AT THIS TIME, NO CONCLUSIONS CAN BE MADE. 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 VENTRALEX (DEVICE #2). AN ADDITIONAL EMDR WAS SUBMITTED TO REPRESENT THE BARD/DAVOL 3DMAX (DEVICE #1). THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD. NOT RETURNED.

    Description of Event or Problem · 1

    THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: ON (B)(6) 2015: THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL 3DMAX (DEVICE #1) AND A BARD/DAVOL VENTRALEX (DEVICE #2). THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE 3DMAX (DEVICE #1) AND THE VENTRALEX (DEVICE #2). THE PATIENT'S 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.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641792 MESH - VENTRALEX SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. -1213643 NA HUZG0219

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Disability| R