MESH - VENTRALEX
Report
- Report Number
- 1213643-2023-093726
- Event Type
- Injury
- Date Received
- September 20, 2023
- Date of Event
- July 10, 2020
- Report Date
- August 6, 2025
- Manufacturer
- DAVOL INC., SUB. C.R. BARD, INC. -1213643
- Product Code
- FTL
- UDI-DI
- 00801741016479
- PMA / PMN Number
- K132441
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- RI, US
- Reporter Occupation
- 003
Narratives
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. ADDENDUM: H11: THIS IS AN ADDENDUM TO THE INITIAL EMDR SUBMITTED (MDR NUMBER 1213643-2023-093726). THIS SUPPLEMENTAL EMDR IS SUBMITTED TO UPDATE THE OUTCOMES ATTRIBUTED TO ADV EV, DATE OF EVENT AND ANNEX F CODE WHICH WAS INADVERTENTLY OMITTED IN THE INITIAL EMDR. NO CONCLUSIONS CAN BE MADE. THE PATIENT'S ATTORNEY ALLEGES THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION. 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. H3 OTHER TEXT: NOT RETURNED.
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. SHOULD ADDITIONAL INFORMATION BE PROVIDED, A SUPPLEMENTAL EMDR WILL BE SUBMITTED. 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. H3 OTHER TEXT : NOT RETURNED.
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. ADDENDUM #1: H11: THIS IS AN ADDENDUM TO THE INITIAL EMDR SUBMITTED (MDR NUMBER 1213643-2023-093726). THIS SUPPLEMENTAL EMDR IS SUBMITTED TO UPDATE THE OUTCOMES ATTRIBUTED TO ADV EV, DATE OF EVENT AND ANNEX F CODE WHICH WAS INADVERTENTLY OMITTED IN THE INITIAL EMDR. NO CONCLUSIONS CAN BE MADE. THE PATIENT'S ATTORNEY ALLEGES THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION. ADDENDUM #2: 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-FEB-2018) 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.
ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF UNSPECIFIED BARD/DAVOL VENTRALEX AND VENTRIO ST ON (B)(6) 2018 AND/OR (B)(6) 2020. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST VENTRALEX. ATTORNEY ALLEGES THAT THE PATIENT HAD REVISION SURGERY ON (B)(6) 2020. 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.
ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF UNSPECIFIED BARD/DAVOL VENTRALEX AND VENTRIO ST ON (B)(6) 2018 AND/OR (B)(6) 2020. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST VENTRALEX. ATTORNEY ALLEGES THAT THE PATIENT HAD REVISION SURGERY ON (B)(6) 2020. 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.
ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF UNSPECIFIED BARD/DAVOL VENTRALEX AND VENTRIO ST ON (B)(6) 2018 AND/OR (B)(6) 2020. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST VENTRALEX. ATTORNEY ALLEGES THAT THE PATIENT HAD REVISION SURGERY ON (B)(6) 2020. 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) 2018 ¿ PATIENT WAS DIAGNOSED WITH INCARCERATED VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX MESH (DEVICE #1). PER OPERATIVE NOTES, ¿IN RIGHT MID QUADRANT, THE HERNIA SAC WAS IDENTIFIED AND DISSECTED FREE. A MEDIUM SIZE VENTRALEX MESH (DEVICE #1) WAS PLACED INTO THE DEFECT AND SUTURED IN PLACE.¿ (B)(6) 2020 - PATIENT HAD PAIN AND DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC CONVERTED TO OPEN REPAIR WITH PARTIAL REMOVAL OF VENTRALEX MESH (DEVICE #1) AND IMPLANT OF VENTRIO ST MESH (DEVICE #2). PER OPERATIVE NOTES, ¿DENSE ADHESIONS OF SMALL BOWEL TO PREVIOUSLY PLACED MESH (DEVICE #1) AND HERNIATED CONTENTS WERE REMOVED. THE MESH (DEVICE #1) WAS PARTIALLY REMOVED AND PIECE OF MESH WAS LEFT IN PLACE TO PREVENT INJURY TO BOWEL. THE VENTRIO ST MESH (DEVICE #2) WAS PLACED AROUND THE DEFECT AND SECURED CIRCUMFERENTIALLY WITH SUTURES. THE REMAINING MESH (DEVICE #1) WAS REAPPROXIMATED OVER TOP OF NEWLY PLACED MESH (DEVICE #2).¿
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 88683 | MESH - VENTRALEX | SURGICAL MESH | FTL | DAVOL INC., SUB. C.R. BARD, INC. -1213643 | NA | HUCP1169 | 00801741016479 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | Female | Required Intervention| S |