MESH SOFRADIM - PARIETEX¿ OPTIMIZED COMPOSITE MESH
Report
- Report Number
- 9615742-2019-00531
- Event Type
- Injury
- Date Received
- March 20, 2019
- Report Date
- July 26, 2024
- Manufacturer
- SOFRADIM PRODUCTION SAS
- Product Code
- FTL
- UDI-DI
- 10884521179790
- PMA / PMN Number
- K110815
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- 003
Narratives
THIS INFORMATION WAS RECEIVED AS A PART OF AN EXTENSIVE MESH LITIGATION SUBMISSION TO MEDTRONIC. THE FDA WAS NOTIFIED OF THIS LARGE COMPLAINT RECEIPT. DUE TO THE VOLUME OF COMPLAINT INFORMATION RECEIVED BY MEDTRONIC, THIS RESULTED IN A REPORT BEYOND THE 30 DAY TARGET. ADDITIONAL INFORMATION: A1, A5B, B5, B7, D11, G4 CORRECTED INFORMATION: A4(WEIGHT IN LBS) 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 INFORMATION: B5, D8, E1 (INITIAL REPORTER: FACILITY NAME, STREET 1, CITY, REGION, POSTAL CODE), H6 (ADDED PATIENT, DEVICE CODES, AND IMF CODES) IME 2402: ADIPOSE TISSUE 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 INFORMATION: A4, B5, B7, H4, H6 (IMF CODES). 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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
CORRECTION: H6 (REMOVED NO CODE). 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.
THIS INFORMATION WAS RECEIVED AS A PART OF AN EXTENSIVE MESH LITIGATION SUBMISSION TO MEDTRONIC. THE FDA WAS NOTIFIED OF THIS LARGE COMPLAINT RECEIPT. DUE TO THE VOLUME OF COMPLAINT INFORMATION RECEIVED BY MEDTRONIC, THIS RESULTED IN A REPORT BEYOND THE 30 DAY TARGET. ADDITIONAL INFORMATION: (WEIGHT IN LBS), DESCRIPTION OF EVENT OR PROBLEM, TEST/LABORATORY DATA, OTHER RELEVANT HISTORY, DATE RECEIVED BY MFR, DATE RECEIVED BY MFR, MEDICAL PRODUCTS & THERAPY DATES CONTINUATION: 0133116 BARD SORBAFIX (X2), (LOT#S HUYB1102 AND HUYB1096). 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 LAPAROSCOPIC THERAPEUTIC TREATMENT OF AN IN CARCERATED INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RE-HERNIATION INFERIORLY SUPERIORLY TO THE MESH, MESH WAS NOT ATTACHED SUPERIORLY, SEROMA, AND ADHESIONS. THE DEVICES HAD BEEN USED WITH 0133116 BARD SORBAFIX (X2), L OT NUMBERS HUYB1102 AND HUYB1096. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, LAPAROSCOPIC INCARCERATED INCISIONAL HERNIA REPAIR, AND TAKE DOWN OF ADHESIONS. CONCOMITANT DEVICE: BARD SORBAFIX (X2) [LOT #HUYB1102, HUYB1096. PRODUCT ID 0133116].
THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR LAPAROSCOPIC THERAPEUTIC TREATMENT OF AN IN CARCERATED INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RE-HERNIATION INFERIORLY/SUPERIORLY TO THE MESH, MESH WAS NOT ATTACHED SUPERIORLY, SEROMA, PAIN, MESH MIGRATION, FIBROSIS, ADIPOSE TISSUE, AND ADHESIONS. POST-OPERATIVE PATIE NT TREATMENT INCLUDED REVISION SURGERY, LAPAROSCOPIC INCARCERATED INCISIONAL HERNIA REPAIR, REMOVAL OF MESH, AND TAKE DOWN OF ADHESIONS.
THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR LAPAROSCOPIC THERAPEUTIC TREATMENT OF AN INCARCERATED INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RE-HERNIATION INFERIORLY/SUPERIORLY TO THE MESH, MESH WAS NOT ATTACHED SUPERIORLY, SEROMA, PAIN, MESH MIGRATION, FIBROSIS, ADIPOSE TISSUE, ADHESIONS, RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, LAPAROSCOPIC INCARCERATED INCISIONAL HERNIA REPAIR, REMOVAL OF MESH, TAKE DOWN OF ADHESIONS, HERNIA REPAIR WITH NEW MESH, MEDICATION.
THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR LAPAROSCOPIC THERAPEUTIC TREATMENT OF AN IN CANCERATED INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RE-HERNIATION INFERIORLY & SUPERIORLY TO THE MESH, MESH WAS NOT ATTACHED SUPERIORLY, SEROMA, AND ADHESIONS. THE DEVICES HAD BEEN USED WITH 0133116 BARD SORBAFIX (X2), L OT NUMBERS HUYB1102 AND HUYB1096. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, LAPAROSCOPIC INCARCERATED INCISIONAL HERNIA REPAIR, AND TAKE DOWN OF ADHESIONS.
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 RE-HERNIATION INFERIORLY & SUPERIORLY TO THE MESH, MESH WAS NOT ATTACHED SUPERIORLY, SEROMA AND ADHESIONS. THE DEVICES HAD BEEN USED WITH 0133116 BARD SORBAFIX (X2), LOT NUMBERS HUYB1102 AND HUYB1096. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 229240 | MESH SOFRADIM - PARIETEX¿ OPTIMIZED COMPOSITE MESH | MESH, SURGICAL, POLYMERIC | FTL | SOFRADIM PRODUCTION SAS | PCO15X | PND0924 | 10884521179790 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Required Intervention | PCO2015X PARIETEX PCOX 20X15CM X1 (LOT# PNG0659X) |