BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTRALIGHT ST W/ ECHO

    MDR report key: 10865685 · Received November 18, 2020

    Report

    Report Number
    1213643-2020-10420
    Event Type
    Injury
    Date Received
    November 18, 2020
    Date of Event
    October 3, 2018
    Report Date
    August 19, 2025
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC. -1213643
    Product Code
    FTL
    UDI-DI
    00801741031717
    PMA / PMN Number
    K130968
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO CONCLUSIONS CAN BE MADE. THE PATIENT'S ATTORNEY ALLEGES ADVERSE PATIENT OUTCOME ASSOCIATED WITH THE HERNIA MESH USED TO TREAT THE PATIENT. THE PATIENT'S ATTORNEY ALLEGES THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION; HOWEVER, NO DETAILS HAVE BEEN PROVIDED. NO LOT NUMBER HAS BEEN PROVIDED; THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE. ADDENDUM: H11: THIS SUPPLEMENTAL EMDR IS SUBMITTED TO DOCUMENT ADDITIONAL INFORMATION PROVIDED AND TO CORRECT THE 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. 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 AN UNSPECIFIED BARD/DAVOL VENTRALIGHT ST ON (B)(6) 2017. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE VENTRALIGHT ST. IT IS ALLEGED THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. ATTORNEY ALLEGES THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE. ADDENDUM PER ADDITIONAL INFORMATION PROVIDED: (B)(6) 2017 ¿ PATIENT WAS DIAGNOSED WITH LEFT INGUINAL HERNIA, LEFT LOWER QUADRANT AND RIGHT LOWER QUADRANT ABDOMINAL PAIN, ADHESIONS THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF VENTRALIGHT ST USING ECHO PS. PER OPERATIVE NOTES, ¿A LONG THIN ADHESION FROM THE COLON TO NEAR UMBILICUS TO THE EDGE OF OLD WELL INCORPORATED UMBILICAL HERNIORRHAPHY MESH. A SMALL LEFT INGUINAL HERNIA WAS NOTED. A ROUND VENTRALIGHT ST USING ECHO PS WAS PLACED TO COVER THE LEFT INGUINAL HERNIA DEFECT AND SECURED USING ABSORBABLE TACKS. APPENDECTOMY WAS PERFORMED¿ (NOTE: THE PREVIOUSLY PLACED MESH SEEN DURING THIS PROCEDURE WAS UNKNOWN). (B)(6) 2018 ¿ PATIENT WAS DIAGNOSED WITH LEFT LOWER QUADRANT PAIN, INTERNAL HERNIA, OMENTAL ADHESIONS THEREBY UNDERWENT LAPAROSCOPIC REPAIR. PER OPERATIVE NOTES, ¿ADHESIONS TOWARDS THE MESH WAS LYSED. THE VENTRALIGHT ST USING ECHO PS WAS WELL INCORPORATED INTO THE WALL. INTERNAL HERNIA IN COLON APPENDAGE WAS ADHERENT WITH OMENTUM WAS RESECTED."

    Additional Manufacturer Narrative · 1

    NO CONCLUSIONS CAN BE MADE. THE PATIENT'S ATTORNEY ALLEGES ADVERSE PATIENT OUTCOME ASSOCIATED WITH THE HERNIA MESH USED TO TREAT THE PATIENT. THE PATIENT'S ATTORNEY ALLEGES THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION; HOWEVER, NO DETAILS HAVE BEEN PROVIDED. NO LOT NUMBER HAS BEEN PROVIDED; THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE. 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 AN UNSPECIFIED BARD/DAVOL VENTRALIGHT ST ON (B)(6) 2017. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE VENTRALIGHT ST. IT IS ALLEGED THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. ATTORNEY ALLEGES THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1330030 VENTRALIGHT ST W/ ECHO SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. -1213643 NA HUAY1518 00801741031717

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Female Required Intervention