BARD MESH PRE-SHAPED W/ KEYHOLE
Report
- Report Number
- 1213643-2018-00274
- Event Type
- Injury
- Date Received
- February 13, 2018
- Date of Event
- July 20, 2016
- Report Date
- July 17, 2024
- Manufacturer
- DAVOL INC., SUB. C.R. BARD, INC.
- Product Code
- FTL
- UDI-DI
- 00801741016554
- PMA / PMN Number
- PREAMENDMENT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- RI, US
- Reporter Occupation
- 003
Narratives
THERE IS NO CONNECTION THAT CAN BE MADE AT THIS TIME BETWEEN THE REPORTED POST-OPERATIVE COMPLICATIONS AND ANY PROBLEM WITH THE BARD/DAVOL DEVICE USED TO TREAT THE PATIENT. THE PATIENT'S ATTORNEY DID NOT ALLEGE A SPECIFIC DEVICE FAILURE OR PATIENT OUTCOME ASSOCIATED WITH THE FALT MESH USED TO REPAIR THE BILATERAL INGUINAL HERNIAS IMPLANTED ON (B)(6) 2015. NO MEDICAL RECORDS HAVE BEEN PROVIDED. 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 MANUFACTURING DATE. BASED ON THE ADDITIONAL INFORMATION RECEIVED, THERE IS NO CHANGE TO INITIAL DETERMINATION, NO CONCLUSIONS CAN BE MADE. PER MEDICAL RECORDS REVIEW, ABOUT 6 MONTHS LATER PATIENT WAS DIAGNOSED WITH MESH MIGRATION, HERNIA RECURRENCE, PAIN AND SCAR TISSUE THEREBY UNDERWENT REPAIR. PER OP NOTES, "THE PREVIOUSLY PLACED MESH APPEARS TO HAVE DETACHED FROM THE PUBIC TUBERCLE". REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND FOUND THAT THE LOT WAS MANUFACTURED TO SPECIFICATION. UPDATE FIELDS. CORRECTED FIELD: H4 (MANUFACTURING DATE) THIS SUPPLEMENTAL EMDR REPRESENTS THE BARD MESH PRE-SHAPED W/ KEYHOLE (DEVICE #1). ADDITIONAL SUPPLEMENTAL EMDR'S WERE SUBMITTED TO REPRESENT THE BARD MESH PRE-SHAPED W/ KEYHOLE (DEVICE #2) AND VENTRALEX ST (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. H3 OTHER TEXT : NOT RETURNED.
THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: ON (B)(6) 2015: THE PATIENT UNDERWENT SURGERY FOR REPAIR OF A BILATERAL INGUINAL HERNIA. AS REPORTED, TWO BARD/DAVOL MARLEX, REFERENCE NUMBERS 0112710, LOT NUMBERS HUZG1675 (DEVICE #1 AND DEVICE #2) WERE IMPLANTED TO REPAIR THE HERNIA DEFECT AND A BARD/DAVOL VENTRALEX ST, REFERENCE NUMBER 5950009, LOT NUMBER HUZG0235 (DEVICE #3) WAS IMPLANTED TO REPAIR A VENTRAL HERNIA DEFECT. ON (B)(6) 2016: THE PATIENT UNDERWENT AN ADDITIONAL SURGERY "TO A RECURRENT VENTRAL HERNIA." AS ALLEGED, THE PATIENT WAS INJURED SEVERELY AND PERMANENTLY AND HAS SUFFERED AND WILL CONTINUE TO SUFFER PHYSICAL PAIN DUE TO THE ALLEGED DEFECTIVE MESH PRODUCTS. ADDENDUM PER ADDITIONAL INFORMATION PROVIDED: ON (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH INCARCERATED VENTRAL HERNIA JUST BELOW THE UMBILICUS AND BILATERAL REDUCIBLE DIRECT INGUINAL HERNIAS THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF TWO BARD MESH PRE-SHAPED W/ KEYHOLE (DEVICE #1 & #2) AND VENTRALEX ST MESH (DEVICE #3). PER OPERATIVE NOTES, ¿IN RIGHT INGUINAL REGION NOTED A DIRECT HERNIA WITH WEAKENED FLOOR. THE FLOOR WAS INITIALLY REPAIRED BY IMBRICATING HERNIA USING STITCH. THIS WAS FURTHER REINFORCED USING A BARD MESH PRE-SHAPED W/ KEYHOLE (DEVICE #1), ANCHORED TO PUBIC TUBERCLE INFERIORLY, INGUINAL LIGAMENT LATERALLY AND CONJOINED TENDON MEDIALLY. THE TWO STRAPS WERE WRAPPED AROUND THE CORD STRUCTURES AT THE INTERNAL RING AND MESH WAS TUGGED UNDERNEATH FASCIA. SIMILARLY DONE IN THE LEFT INGUINAL REGION WITH A BARD MESH PRE-SHAPED W/ KEYHOLE (DEVICE #2). THEN HERNIA WAS IDENTIFIED IN THE INFRAUMBILICAL REGION, JUST BELOW THE UMBILICUS ATTACHMENT. THIS WAS SEPARATED AND THE PERITONEAL FAT REDUCED BACK INTO THE PREPERITONEAL SPACE. A ROUND VENTRALEX ST MESH (DEVICE #3) WAS PLACED AGAINST THE ABDOMINAL WALL. THE STRAPS WERE CUT AND MESH TUCKED UNDERNEATH THE FACIA USING STITCHES.¿ ON (B)(60 2015 - PATIENT HAD POST OPERATIVE VISITS AND HAD SWELLING, BULGE, PAIN, UPPER ABDOMINAL DISCOMFORT, NUMBNESS IN THE AREA BELOW INGUINAL INCISIONS AND FATTY TISSUE IN THE EPIGASTRIUM ABOVE THE UMBILICUS THEREBY PROVIDED WITH MEDICATIONS. ON (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH VENTRAL HERNIA (SUPRAUMBILICAL PLUS EPIGASTRIC) THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF SYNTHETIC MESH. PER OPERATIVE NOTES, ¿ADHESIONS WERE TAKEN DOWN. THE HERNIA DEFECT IDENTIFIED ABOVE THE PREVIOUSLY PLACED MESH (DEVICE #3 - VENTRALEX ST MESH). THE INCARCERATED PREPERITONEAL FAT WAS REDUCED BACK INTO THE PERITONEAL CAVITY. A ROUND SYNTHETIC (SYMBOTEX) MESH WAS PLACED. PREVIOUSLY PLACED SUTURES WERE PULLED UP TOWARDS ABDOMINAL WALL, THE MESH LEFT LYING FLAT AGAINST THE ABDOMINAL WALL AND TACKED.¿ ON (B)(6) 2016 - PATIENT HAD POST OPERATIVE VISITS AND HAD INGUINAL PAIN AND DIAGNOSED WITH BILATERAL HERNIA RECURRENCE. ON (B)(6) 2016 - PATIENT UNDERWENT OPEN RECURRENT BILATERAL INGUINAL HERNIA REPAIR WITH THE IMPLANT OF TWO PERFIX PLUGS (DEVICE #4 & #5). PER OPERATIVE NOTES, ¿SCAR TISSUES AND DIRECT HERNIA WAS NOTED IN THE RIGHT INGUINAL FLOOR. THE PREVIOUSLY PLACED MESH (DEVICE #1) APPEARS TO HAVE DETACHED FROM THE PUBIC TUBERCLE. THE HERNIA WAS REDUCED BACK AND A MEDIUM PERFIX PLUG (DEVICE #4) PLACED IN THE DEFECT FOLLOWED BY REATTACHMENT OF PREVIOUSLY PLACED KEYHOLE MESH TO THE PUBIC TUBERCLE. IN THE LEFT INGUINAL REGION SIMILAR REPAIR PERFORMED USING A SMALL PERFIX PLUG (DEVICE #5) AND PREVIOUSLY PLACED MESH (DEVICE #2) WAS REATTACHED TO THE PUBIC TUBERCLE.¿ ON (B)(6) 2016 - PATIENT HAD POST OPERATIVE VISIT AND HAD SWELLING AND PAIN MORE ON RIGHT THAN ON LEFT WHICH EVENTUALLY IMPROVED. ATTORNEY ALLEGES THAT THE PATIENT HAD PAIN, HERNIA RECURRENCE AND EMOTIONAL INJURIES.
THERE IS NO CONNECTION THAT CAN BE MADE AT THIS TIME BETWEEN THE REPORTED POST-OPERATIVE COMPLICATIONS AND ANY PROBLEM WITH THE BARD/DAVOL DEVICE USED TO TREAT THE PATIENT. THE PATIENT'S ATTORNEY DID NOT ALLEGE A SPECIFIC DEVICE FAILURE OR PATIENT OUTCOME ASSOCIATED WITH THE FALT MESH USED TO REPAIR THE BILATERAL INGUINAL HERNIAS IMPLANTED ON (B)(6) 2015. NO MEDICAL RECORDS HAVE BEEN PROVIDED. 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 FLAT MESH (DEVICE #1). ADDITIONAL EMDR HAVE BEEN SUBMITTED TO REPRESENT THE BARD FLAT MESH (DEVICE #2) AND BARD VENTRALEX ST (DEVICE #3). 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.
THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: ON (B)(6) 2015: THE PATIENT UNDERWENT SURGERY FOR REPAIR OF A BILATERAL INGUINAL HERNIA. AS REPORTED, TWO BARD/DAVOL MARLEX, REFERENCE NUMBERS 0112710, LOT NUMBERS HUZG1675 (DEVICE #1 AND DEVICE #2) WERE IMPLANTED TO REPAIR THE HERNIA DEFECT AND A BARD/DAVOL VENTRALEX ST, REFERENCE NUMBER 5950009, LOT NUMBER HUZG0235 (DEVICE #3) WAS IMPLANTED TO REPAIR A VENTRAL HERNIA DEFECT. ON (B)(6) 2016: THE PATIENT UNDERWENT AN ADDITIONAL SURGERY "TO A RECURRENT VENTRAL HERNIA." AS ALLEGED, THE PATIENT WAS INJURED SEVERELY AND PERMANENTLY AND HAS SUFFERED AND WILL CONTINUE TO SUFFER PHYSICAL PAIN DUE TO THE ALLEGED DEFECTIVE MESH PRODUCTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 111091 | BARD MESH PRE-SHAPED W/ KEYHOLE | SURGICAL MESH | FTL | DAVOL INC., SUB. C.R. BARD, INC. | NA | HUZG1675 | 00801741016554 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Male | Disability| R |