MESH SOFRADIM - PARIETEX¿ COMPOSITE MESH
Report
- Report Number
- 9615742-2017-06104
- Event Type
- Death
- Date Received
- December 14, 2017
- Report Date
- August 30, 2023
- Manufacturer
- SOFRADIM PRODUCTION SAS
- Product Code
- FTL
- PMA / PMN Number
- K110816
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- ATTORNEY
- Health Professional
- N
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 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.
ADDITIONAL INFO: A1, A4, A5B, B5, B6, B7, & H6 (PATIENT CODES, IME E2402: LEUKOCYTOSIS) 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.
THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MENTAL PAIN, PHYSICAL DEFORMITY, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DISFIGUREMENT, MENTAL ANGUISH, PAIN, NECROTIC TISSUE, INDURATION, BACTERIAL INFECTION, MRSA, WOUND DEHISCENCE, RECURRENCE, HYPERTENSION, ABDOMINAL COMPARTMENT SYNDROME, NON-HEALING WOUND, SEROMA, HEMATOMA, INFECTION, ADHESIONS, AND DEATH. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF PARIETENE, PLACEMENT OF VICRYL MESH, HERNIA REPAIR WITH PARIETENE, OPEN REPAIR OF HERNIA, MOBILIZATION OF BOWEL, BILATERAL RELEASE OF ABDOMINAL WALL, RESUSCITATION, MULTIPLE ICU VISITS, INTUBATION, SEDATION, OPEN WOUND DEBRIDEMENT, TAKE DOWN OF ADHESIONS, DRAIN PLACEMENT, DAILY HOME CARE SERVICES, ADMISSION TO HOSPITAL, WOUND VAC, REVISION SURGERY, AND REMOVAL OF MESH. INFORMATION RECEIVED INDICATES THE PATIENT IS DECEASED. NO INFORMATION WAS PROVIDED REGARDING THE CIRCUMSTANCES OF EXPIRATION.
THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED SKIN ULCERATION, MENTAL PAIN, PHYSICAL DEFORMITY, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DISFIGUREMENT, MENTAL ANGUISH, PAIN, NECROTIC TISSUE, INDURATION, BACTERIAL INFECTION, MRSA, WOUND DEHISCENCE, RECURRENCE, HYPERTENSION, ABDOMINAL COMPARTMENT SYNDROME, NON-HEALING WOUND, SEROMA, HEMATOMA, INFECTION, ADHESIONS, AND DEATH. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF PARIETENE, PLACEMENT OF VICRYL MESH, HERNIA REPAIR WITH PARIETENE, OPEN REPAIR OF HERNIA, MOBILIZATION OF BOWEL, BILATERAL RELEASE OF ABDOMINAL WALL, RESUSCITATION, MULTIPLE ICU VISITS, INTUBATION, SEDATION, OPEN WOUND DEBRIDEMENT, TAKE DOWN OF ADHESIONS, DRAIN PLACEMENT, DAILY HOME CARE SERVICES, ADMISSION TO HOSPITAL, WOUND VAC, REVISION SURGERY, AND REMOVAL OF MESH. INFORMATION RECEIVED INDICATES THE PATIENT IS DECEASED. NO INFORMATION WAS PROVIDED REGARDING THE CIRCUMSTANCES OF EXPIRATION.
THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED SKIN ULCERATION, MENTAL PAIN, PHYSICAL DEFORMITY, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DISFIGUREMENT, MENTAL ANGUISH, PAIN, NECROTIC TISSUE, INDURATION, BACTERIAL INFECTION, MRSA, WOUND DEHISCENCE, RECURRENCE, HYPERTENSION, ABDOMINAL COMPARTMENT SYNDROME, NON-HEALING WOUND, SEROMA, HEMATOMA, INFECTION, ADHESIONS, SCANT CORYNEBACTERIUM, ENTEROCOCCUS FAECALIS, MESH EXPOSED, ABDOMINAL PAIN, BRUISING OF THE OMENTUM, KIDNEY FAILURE, RESPIRATORY FAILURE, LEUKOCYTOSIS, WOUND INFECTION, AND DEATH. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF PARIETENE, PLACEMENT OF VICRYL MESH, HERNIA REPAIR WITH PARIETENE, OPEN REPAIR OF HERNIA, MOBILIZATION OF BOWEL, BILATERAL RELEASE OF ABDOMINAL WALL, RESUSCITATION, MULTIPLE ICU VISITS, INTUBATION, SEDATION, OPEN WOUND DEBRIDEMENT, TAKE DOWN OF ADHESIONS, DRAIN PLACEMENT, DAILY HOME CARE SERVICES, ADMISSION TO HOSPITAL, WOUND VAC, REVISION SURGERY, REMOVAL OF MESH, CT SCAN, ANTIBIOTICS, USE OF VELCRO BINDER, PAIN MEDICATION, WOUND CARE, IV FLUIDS, IV ANTIBIOTICS, BIPAP, MEDICALLY INDUCED PARALYSIS, REINTUBATION, & PARTIAL OMENTUM REMOVAL. INFORMATION RECEIVED INDICATES THE PATIENT IS DECEASED. NO INFORMATION WAS PROVIDED REGARDING THE CIRCUMSTANCES OF EXPIRATION.
EVALUATION SUMMARY: TO DATE, THE INCIDENT SAMPLE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED, OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED. 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.
THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE RESULTING IN AN UNSPECIFIED ADVERSE OUTCOME. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. THE PATIENT UNDERWENT AN INCISIONAL HERNIA REPAIR WITH MESH. SHE HAD REVISION SURGERY TWO MONTHS POST-SURGERY. THE PATIENT EXPERIENCED UN-HEALING WOUND, DEVELOPED SEROMA, HEMATOMA AND INFECTION AND THE MESH WAS REMOVED ABOUT FIVE MONTHS LATER. THE OPERATIVE NOTE FOR REMOVAL STATES THE MESH HAD ADHERED DESPITE AN ANTI-ADHESIVE BARRIER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 895820 | MESH SOFRADIM - PARIETEX¿ COMPOSITE MESH | MESH, SURGICAL, POLYMERIC | FTL | SOFRADIM PRODUCTION SAS | PCO2015 | PFK00433 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention| L| D| H| S |