BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTRALIGHT ST W/ ECHO

    MDR report key: 8139248 · Received December 6, 2018

    Report

    Report Number
    1213643-2018-04454
    Event Type
    Injury
    Date Received
    December 6, 2018
    Date of Event
    November 4, 2016
    Report Date
    March 31, 2026
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC. -1213643
    Product Code
    FTL
    UDI-DI
    00801741031786
    PMA / PMN Number
    K122436
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AT THIS TIME NO CONCLUSIONS CAN BE MADE TO WHAT EXTENT THE BARD/DAVOL VENTRALIGHT ST(DEVICE #1)MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE CAUSE OF THE PATIENT POSTOPERATIVE COMPLICATIONS CANNOT BE DETERMINED AT THIS TIME. RECURRENCE AND ADHESIONS IS A KNOWN INHERENT RISK OF SURGERY AND IS LISTED IN THE INSTRUCTIONS-FOR-USE A POSSIBLE COMPLICATION. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND FOUND THAT THE LOT WAS MANUFACTURED TO SPECIFICATION. BASED ON THE LIMITED INFORMATION PROVIDED AT THIS TIME, NO CONCLUSIONS CAN BE MADE. 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-OCT-2015) IS CONSIDERED TO BE A BEST ESTIMATE. UPDATED FIELDS: A2, B2, B4, B5, B7, D3, D4 (PRODUCT CATALOG NO., CORPORATE LOT NO., EXPIRY DATE, UDI NO), G1, G3, G6, H2, H4, H6, H10, H11. CORRECTED FIELD: D1 (BRAND NAME), G4 (PMA/510(K)). THIS SUPPLEMENTAL EMDR REPRESENTS THE BARD/DAVOL VENTRALIGHT ST WITH ECHO MESH (DEVICE 1). AN ADDITIONAL SUPPLEMENTAL EMDR WAS SUBMITTED TO REPRESENT THE BARD/DAVOL VENTRALIGHT ST WITH ECHO MESH (DEVICE 2) AND VENTRALIGHT ST WITH ECHO MESH (DEVICE 3). 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) 2016 - PATIENT UNDERWENT AN INCISIONAL HERNIA REPAIR. A VENTRALIGHT ST (DEVICE #1) WAS IMPLANTED IN PATIENT DURING THIS REPAIR. (B)(6) 2016: THE PATIENT UNDERWENT A RECURRENT INCISION HERNIA REPAIR. UPON ENTERING THE PATIENT'S ABDOMEN, THE SURGEON NOTED THAT THE HERNIA HAD RECURRED ALONG THE EDGE OF THE MESH, AND THAT OMENTUM HAD ADHERED TO THE MESH AND REQUIRED TO BE CLEARED WITH SCISSORS, SHARPS AND CAUTERY DISSECTION. TWO (2) ADDITIONAL UNSPECIFIED BARD/DAVOL VENTRALIGHT ST (DEVICE #2 AND DEVICE #3) WERE USED TO ADDRESS THE DEFECT. SINCE THE SECOND HERNIA PROCEDURE, SHE HAS CONTINUED TO EXPERIENCE PAIN IN HER LOWER ABDOMEN AND HAS CONTINUED TO SEEK TREATMENT FOR PAIN AND INTERNAL ISSUES FROM THE SURGEON AND OTHER PROVIDERS. VENTRALIGHT ST (DEVICE #1, DEVICE #2 AND DEVICE #3) IMPLANTED IN PATIENT FAILED TO REASONABLY PERFORM AS INTENDED. THE VENTRALIGHT ST (DEVICE #1) CAUSED SERIOUS INJURY AND HAD TO BE SURGICALLY REMOVED INVASIVE SURGERY, NECESSITATING ADDITIONAL INVASIVE SURGERY TO REPAIR THE HERNIA THAT THE VENTRALIGHT ST (DEVICE #1) WAS INITIALLY IMPLANTED TO TREAT. THE PATIENT WAS CAUSED TO SUFFER SEVERE PERSONAL INJURIES, PAIN AND SUFFERING, AND OTHER DAMAGES. AS REPORTED, PATIENT HAS BEEN INJURED SUSTAINED SEVERE AND PERMANENT PAIN, SUFFERING, ANXIETY, DEPRESSION, DISABILITY, IMPAIRMENT DUE TO THE ALLEGED DEFECTIVE VENTRALIGHT ST (DEVICE #1, DEVICE #2 AND DEVICE #3). ADDENDUM PER ADDITIONAL INFORMATION PROVIDED: (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF VENTRALIGHT ST W/ ECHO MESH (DEVICE 1). PER OPERATIVE NOTES, ¿AN INCISION WAS MADE INTO THE LEFT LATERAL ABDOMEN. THE HERNIA SAC WAS DISSECTED OUT. A 25X 20 CM PIECE OF VENTRALIGHT ST W/ ECHO MESH (DEVICE 1) WAS PLACED INTO THE ABDOMEN AND SECURE IT WITH SUTURES.¿ (B)(6) 2016 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT 2 SEPARATE INCISIONAL HERNIA, ADHESION THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF VENTRALIGHT ST W/ ECHO MESH (DEVICE 2 AND DEVICE 3). PER OPERATIVE NOTES, ¿AN INCISION WAS MADE INTO THE LOWER MIDLINE. THE HERNIA SAC WAS DISSECTED OUT. THERE WAS LOT OF ADHESIONS WHICH WERE DISSECTED OUT. A VENTRALIGHT ST W/ ECHO MESH (DEVICE 2) WAS PLACED INTO THE LOWER DEFECT AND CLOSED WITH SUTURES. AN INCISION WAS MADE INTO THE UPPER MIDLINE. THE HERNIA SAC WAS DISSECTED OUT. A VENTRALIGHT ST W/ ECHO MESH (DEVICE 3) WAS PLACED INTO THE UPPER DEFECT AND CLOSED WITH SUTURES.¿

    Additional Manufacturer Narrative · 1

    AT THIS TIME NO CONCLUSIONS CAN BE MADE TO WHAT EXTENT THE BARD/DAVOL VENTRALIGHT ST (DEVICE #1) MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE CAUSE OF THE PATIENT POSTOPERATIVE COMPLICATIONS CANNOT BE DETERMINED AT THIS TIME. RECURRENCE AND ADHESIONS IS A KNOWN INHERENT RISK OF SURGERY AND IS LISTED IN THE INSTRUCTIONS-FOR-USE A POSSIBLE COMPLICATION. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND FOUND THAT THE LOT WAS MANUFACTURED TO SPECIFICATION. BASED ON THE LIMITED INFORMATION PROVIDED AT THIS TIME, NO CONCLUSIONS CAN BE MADE. SHOULD ADDITIONAL INFORMATION BE PROVIDED A SUPPLEMENTAL EMDR WILL BE SUBMITTED. THIS EMDR REPRESENTS THE BARD/DAVOL VENTRALIGHT ST (DEVICE #1). AN ADDITIONAL EMDR WAS SUBMITTED TO REPRESENT THE BARD/DAVOL VENTRALIGHT ST (DEVICE #2). AN ADDITIONAL EMDR WAS SUBMITTED TO REPRESENT THE BARD/DAVOL VENTRALIGHT ST(DEVICE #3). NOTE: NOT RETURNED.

    Description of Event or Problem · 1

    THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: ON (B)(6) 2016: PATIENT UNDERWENT AN INCISIONAL HERNIA REPAIR. A VENTRALIGHT ST (DEVICE #1) WAS IMPLANTED IN PATIENT DURING THIS REPAIR. ON (B)(6) 2016: THE PATIENT UNDERWENT A RECURRENT INCISION HERNIA REPAIR. UPON ENTERING THE PATIENT'S ABDOMEN, THE SURGEON NOTED THAT THE HERNIA HAD RECURRED ALONG THE EDGE OF THE MESH, AND THAT OMENTUM HAD ADHERED TO THE MESH AND REQUIRED TO BE CLEARED WITH SCISSORS, SHARPS AND CAUTERY DISSECTION. TWO (2) ADDITIONAL "UNSPECIIFED" BARD/DAVOL VENTRALIGHT ST (DEVICE #2 AND DEVICE #3) WERE USED TO ADDRESS THE DEFECT. SINCE THE SECOND HERNIA PROCEDURE, SHE HAS CONTINUED TO EXPERIENCE PAIN IN HER LOWER ABDOMEN AND HAS CONTINUED TO SEEK TREATMENT FOR PAIN AND INTERNAL ISSUES FROM THE SURGEON AND OTHER PROVIDERS. VENTRALIGHT ST (DEVICE #1, DEVICE #2 AND DEVICE #3) IMPLANTED IN PATIENT FAILED TO REASONABLY PERFORM AS INTENDED. THE VENTRALIGHT ST (DEVICE #1) CAUSED SERIOUS INJURY AND HAD TO BE SURGICALLY REMOVED INVASIVE SURGERY, NECESSITATING ADDITIONAL INVASIVE SURGERY TO REPAIR THE HERNIA THAT THE VENTRALIGHT ST (DEVICE #1)WAS INITIALLY IMPLANTED TO TREAT. THE PATIENT WAS CAUSED TO SUFFER SEVERE PERSONAL INJURIES, PAIN AND SUFFERING, AND OTHER DAMAGES. AS REPORTED, PATIENT HAS BEEN INJURED SUSTAINED SEVERE AND PERMANENT PAIN, SUFFERING, ANXIETY, DEPRESSION, DISABILITY, IMPAIRMENT DUE TO THE ALLEGED DEFECTIVE VENTRALIGHT ST (DEVICE #1, DEVICE #2 AND DEVICE #3).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61847 VENTRALIGHT ST W/ ECHO SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. -1213643 NA HUZJ0273 00801741031786

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female Disability| R