BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTRALIGHT ST W/ ECHO

    MDR report key: 12745515 · Received November 3, 2021

    Report

    Report Number
    1213643-2021-08418
    Event Type
    Injury
    Date Received
    November 3, 2021
    Report Date
    May 20, 2026
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC. -1213643
    Product Code
    FTL
    UDI-DI
    00801741031755
    PMA / PMN Number
    K122436
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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 VENTRALIGHT ST MESH (DEVICE #2). AN ADDITIONAL EMDR WAS SUBMITTED TO REPRESENT THE BARD/DAVOL VENTRIO ST (DEVICE #1). ADDENDUM: H11: THIS SUPPLEMENTAL EMDR IS SUBMITTED TO DOCUMENT ADDITIONAL INFORMATION PROVIDED AND TO CORRECT BRAND NAME AND PMA/510(K). 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-NOV-2016) IS CONSIDERED TO BE A BEST ESTIMATE. THIS SUPPLEMENTAL EMDR REPRESENTS THE BARD/DAVOL VENTRALIGHT ST USING ECHO PS (DEVICE 2). AN ADDITIONAL SUPPLEMENTAL EMDR WAS SUBMITTED TO REPRESENT THE BARD/DAVOL VENTRIO ST 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

    ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF UNSPECIFIED BARD/DAVOL VENTRIO ST AND VENTRALIGHT ST ON (B)(6) 2015 AND/OR (B)(6) 2017. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST BOTH 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. ADDENDUM PER ADDITIONAL INFORMATION PROVIDED: (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH VENTRAL HERNIA AND LEFT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRIO ST (DEVICE 1) AND SYNTHETIC MESH. PER OP NOTES, ¿MIDLINE INCISION WAS MADE AT THE UMBILICUS. THE HERNIA SAC WAS NOTED AND DISSECTED FREE. EXCESS HERNIA SAX WAS REMOVED. A VENTRIO ST (DEVICE 1) WAS PLACED AND TACKED. ON THE LEFT INGUINAL REGION, AN INDIRECT HERNIA SAC WAS IDENTIFIED AND DISSECTED FREE. A SYNTHETIC MESH WAS PLACED AND SUTURED.¿ (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH RECURRENT ABDOMINAL INCISIONAL HERNIA WITH PAIN THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH EXCISION OF VENTRIO ST (DEVICE 1) AND IMPLANT OF VENTRALIGHT ST USING ECHO PS (DEVICE 2). PER OP NOTES, ¿ADHESIONS OF THE BOWEL AND OMENTUM WERE LYSED. THE OLD MESH WAS EXCISED AND REMOVED. TWO HERNIA DEFECTS WERE NOTED AND REDUCED. A VENTRALIGHT ST USING ECHO PS (DEVICE 2) WAS PLACED AND TACKED.¿

    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 VENTRALIGHT ST MESH (DEVICE #2). AN ADDITIONAL EMDR WAS SUBMITTED TO REPRESENT THE BARD/DAVOL VENTRIO ST (DEVICE #1). 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 SURGERY FOR IMPLANT OF UNSPECIFIED BARD/DAVOL VENTRIO ST AND VENTRALIGHT ST ON (B)(6) 2015 AND/OR (B)(6) 2017. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST BOTH 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
    570868 VENTRALIGHT ST W/ ECHO SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. -1213643 NA HUAY0121 00801741031755

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Disability