MESH - SURGIPRO¿
Report
- Report Number
- 1219930-2018-04281
- Event Type
- Injury
- Date Received
- August 6, 2018
- Report Date
- March 17, 2026
- Manufacturer
- COVIDIEN LP LLC NORTH HAVEN
- Product Code
- FTL
- UDI-DI
- 10884521101371
- PMA / PMN Number
- K915526
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- 003
Narratives
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
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. 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.
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. 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 A LEFT INGUINAL HERNIA AND UMBILICAL HERNIA. IT WAS REPORTED THAT AFTER OVERLAY IMPLANT, THE PATIENT EXPERIENCED MESH INFECTION, ADHESIONS, GROIN PAIN, FAILED MESH, PAIN, MENTAL PAIN, DISABILITY, IMPAIRMENT , LOSS OF ENJOYMENT OF LIFE, DEFECTIVE DEVICE, AND RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED LEFT GROIN EXPLORATION AND REMOVAL OF INFECTED MESH.
THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF A LEFT INGUINAL HERNIA AND UMBILICAL HERNIA. IT WAS REPORTED THAT AFTER OVERLAY IMPLANT, THE PATIENT EXPERIENCED MESH INFECTION, ADHESIONS, GROIN PAIN AND RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED LEFT GROIN EXPLORATION AND REMOVAL OF INFECTED MESH. THE DEVICE WAS USED WITH A BARD VENTRALEX ST (PRODUCT ID: 5950007; LOT NO: HUXA0768).
THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF A LEFT INGUINAL HERNIA AND UMBILICAL HERNIA. IT WAS REPORTED THAT AFTER OVERLAY IMPLANT, THE PATIENT EXPERIENCED INFLAMMATION, BLEEDING, ABSCESS, ENLARGED TESTICLE, LOSS OF CORE STRENGTH, MESH INFECTION, ADHESIONS, GROIN PAIN, FAILED MESH, PAIN, MENTAL PAIN, DISABILITY, IMPAIRMENT , LOSS OF ENJOYMENT OF LIFE, DEFECTIVE DEVICE, AND RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED CT SCAN, LEFT GROIN EXPLORATION AND REMOVAL OF INFECTED MESH.
THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF A LEFT INGUINAL HERNIA AND UMBILICAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MESH INFECTION, ADHESIONS, GROIN PAIN AND RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED LEFT GROIN EXPLORATION AND REMOVAL OF INFECTED MESH.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
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 A HERNIA. IT WAS REPORTED THAT AFTER A PROCEDURE WHERE THIS DEVICE WAS IMPLANTED, THE PATIENT EXPERIENCED MESH INFECTION, GROIN PAIN AND ADDITIONAL HERNIA SURGERY. AFTER TREATMENT, THE PATIENT EXPERIENCED REVISION SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 593843 | MESH - SURGIPRO¿ | MESH, SURGICAL, POLYMERIC | FTL | COVIDIEN LP LLC NORTH HAVEN | SPM-35-W | A2J0942X | 10884521101371 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male | Required Intervention| O | 5950007(LOT#:HUXA0768) |