MESH SOFRADIM - PARIETEX¿ COMPOSITE MESH
Report
- Report Number
- 9615742-2021-01610
- Event Type
- Injury
- Date Received
- July 2, 2021
- Report Date
- May 2, 2024
- Manufacturer
- SOFRADIM PRODUCTION SAS
- Product Code
- FTL
- PMA / PMN Number
- K040998
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- 003
Narratives
MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
ADDITIONAL INFO: H6 (PATIENT CODES, DEVICE CODES, IME E2402: SMALL BOWEL ENCASED IN A THICK RIND, LABS ABNORMAL FOR CRP; WBC; BILIRUBIN; PLATELETS; PREALBUMIN, SEROSITIS). MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
CORRECTION: H6 IME E2402: THICKENING OF THE INFERIOR PORTION OF THE MIDLINE WOUND. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR A LAPAROSCOPIC THERAPEUTIC TREATMENT OF A ILEOSTOMY HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, SCARRING, FOREIGN BODY GIANT CELL REACTION, INFLAMMATION, FISTULA, OPEN DRAINING WOUND, THICKENING OF THE INFERIOR PORTION OF THE MIDLINE WOUND, PAIN, AND SMALL BOWEL ENCASED IN A THICK RIND WITH MESH . POST-OPERATIVE PATIENT TREATMENT INCLUDED BOWEL RESECTION, MESH REMOVAL, AND REVISION SURGERY.
THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR A LAPAROSCOPIC THERAPEUTIC TREATMENT OF A ILEOSTOMY HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, SCARRING, FOREIGN BODY GIANT CELL REACTION, INFLAMMATION, FISTULA, OPEN DRAINING WOUND, THICKENING OF THE INFERIOR PORTION OF THE MIDLINE WOUND, PAIN, SMALL BOWEL ENCASED IN A THICK RIND WITH MESH, INFECTION, RECURRENCE, MESH FOUND POSTERIOR TO A LARGE NECROTIC AND INFECTED APPEARING POCKET, PURULENT FLUID, PLATEAU IN WOUND HEALING, SCAR TISSUE. POST-OPERATIVE PATIENT TREATMENT INCLUDED BOWEL RESECTION, MESH REMOVAL, REVISION SURGERY, ABDOMINAL EXPLORATION, LYSIS OF ADHESIONS, APPENDECTOMY, DEBRIDEMENT OF ABDOMINAL WALL FASCIA, SKIN AND SUBCUTANEOUS FAT, PARTIAL CLOSURE OF ABDOMINAL WALL, WOUND VAC.
THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR A LAPAROSCOPIC THERAPEUTIC TREATMENT OF A ABDOMINAL INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, SCARRING, FOREIGN BODY GIANT CELL REACTION, INFLAMMATION, FISTULA, OPEN DRAINING WOUND, THICKENING OF THE INFERIOR PORTION OF THE MIDLINE WOUND, PAIN, SMALL BOWEL ENCASED IN A THICK RIND WITH MESH, INFECTION, RECURRENCE, LARGE NECROTIC/INFECTED APPEARING POCKET, PURULENT FLUID, PLATEAU IN WOUND HEALING, SCAR TISSUE, FLUID COLLECTION, ABSCESS, HEMATOMA, LABS ABNORMAL FOR CRP; CHLORIDE; WBC; BILIRUBIN; PLATELETS; PREALBUMIN, SEROSITIS, ABDOMINAL PAIN, ERYTHEMA, SEROSANGUINEOUS DRAINAGE, FEVER, ANXIETY, AMBULATION DIFFICULTIES, & DIARRHEA/LOOSE BOWEL MOVEMENT. POST-OPERATIVE PATIENT TREATMENT INCLUDED BOWEL RESECTION, MESH REMOVAL, REVISION SURGERY, ABDOMINAL EXPLORATION, LYSIS OF ADHESIONS, APPENDECTOMY, DEBRIDEMENT OF ABDOMINAL WALL FASCIA; SKIN; SUBCUTANEOUS FAT, PARTIAL CLOSURE OF ABDOMINAL WALL, WOUND VAC, CT SCAN, HOSPITALIZATION, SMALL BOWEL ANASTOMOSIS, BILATERAL FLAP CREATION, NPO, NG TUBE, IV ANTIBIOTICS, IV FLUIDS, ANTI-ANXIETY MEDICATION, IV/ORAL PAIN MEDICATION, AMBULATION ASSISTANCE WITH WHEELED WALKER, USE OF ABDOMINAL BINDER, INCISION & DRAINAGE OF ABSCESS, MESH REVISION, & WOUND CARE.
CONCOMITANT DEVICES: BARD- SEPRALMESH COMPOSITE 6'X8', PRODUCT ID 5959680, LOT # WBTFS078, EXP. DATE 2010-10; BARD- SORBAFIX ABSORBABLE FIXATION SYSTEM, PRODUCT ID 0113080, LOT # DATF0003, EXP. DATE 2010-06 BARD- SORBAFIX ABSORABLE FIXATION SYSTEM, PRODUCT ID 0113082, LOT # DATF0007, EXP. DATE 2010-06, QUANTITY: 03 IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR A LAPAROSCOPIC THERAPEUTIC TREATMENT OF A ILEOSTOMY HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, SCARRING, FOREIGN BODY GIANT CELL REACTION, INFLAMMATION, FISTULA, OPEN DRAINING WOUND, THICKENING OF THE INFERIOR PORTION OF THE MIDLINE WOUND, AND SMALL BOWEL ENCASED IN A THICK RIND WITH MESH . POST-OPERATIVE PATIENT TREATMENT INCLUDED BOWEL RESECTION, MESH REMOVAL, AND REVISION SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1004113 | MESH SOFRADIM - PARIETEX¿ COMPOSITE MESH | MESH, SURGICAL, POLYMERIC | FTL | SOFRADIM PRODUCTION SAS | PCO9 | PIH00352 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Required Intervention| H |