PROGRIP
Report
- Report Number
- 9615742-2025-00324
- Event Type
- Death
- Date Received
- April 9, 2025
- Report Date
- July 18, 2025
- Manufacturer
- SOFRADIM PRODUCTION SAS
- Product Code
- FTL
- UDI-DI
- 10884521177666
- PMA / PMN Number
- K140941
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
D10 CONCOMITANT PRODUCT: PP1208DL PROGRIP LT PPL/PLA 12X8CM (LOT#SYB2020X) 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.
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 INFORMATION: E1 (PREFIX, LAST NAME, FIRST NAME REMOVED), G3 CORRECTION: E3 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.
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 INFORMATION: B2 (DEATH, DATE OF DEATH), B5, G3, H1, H6 CORRECTION: D4 (UNIQUE IDENTIFIER (UDI) #) NEW INFORMATION HAS BEEN RECEIVED PERTAINING TO THE EVENT. THIS EVENT HAS BEEN REASSESSED AND THE REPORTABILITY HAS BEEN DETERMINED TO BE A DEATH. 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 REPORTED THAT ON (B)(6) 2024 AN OPEN BILATERAL INGUINAL HERNIA CURE WAS PERFORMED USING THE LICHTENSTEIN TECHNIQUE WITH THE PLACEMENT OF TWO RETRO-APONEUROTIC PROSTHESES. THE PROCEDURE INVOLVED A DORSOL DECUBITUS POSITION UNDER GENERAL ANESTHESIA, INCISION IN THE RIGHT LOWER ABDOMINAL FOLD, OPENING OF THE EXTERNAL OBLIQUE FASCIA, DISSECTION OF A LARGE EXTERNAL OBLIQUE HERNIA, SPERM CORD RELEASE, DETACHMENT OF APONEUROTIC MARGINS, AND THE SPREAD OF A MESH PROSTHESIS ATTACHED TO THE PUBIS, CRURAL ARCH, AND CONJOINED TENDON BY SEPARATE POINTS OF A SUTURE. THE WOUND WAS CLOSED WITH APONEUROTIC CLOSURE, CLOSURE OF THE FASCIA CRIBRIFORMIS, NAROPENINE WALL INFILTRATION, AND NON-ABSORBABLE THREADS ON THE SKIN. POST OPERATIVELY, THE PATIENT EXPERIENCED SEVERE PAIN, INTERNAL BURNS ON THE RIGHT AND LEFT, NEEDLE STROKE SENSATION, AND UNPLEASANT DISCOMFORT IN THE TESTICLES WITH PAIN. THE PATIENT ALSO REPORTED FEELING AS IF HAVING BRUISES AND AN IMPRESSION OF HAVING CORRUGATED CARDBOARD INSIDE. THESE SYMPTOMS WERE EXACERBATED WHEN STANDING AND SITTING, LEADING TO WAKING UP AT NIGHT DUE TO NEEDLE STROKE AND BURNS, DIFFICULTY GOING BACK TO SLEEP, AND SOMETIMES SLEEPLESS NIGHTS. THE PATIENT FACED GREAT DIFFICULTY IN SQUATTING, STANDING UP, AND LIFTING LOADS, ALONG WITH LOSS OF TONE AND INTENSE FATIGUE. PSYCHOLOGICAL CONSEQUENCES INCLUDED ALTERATION OF MOOD, ANXIETY, STRESS, DEPRESSION, AND MORBID IDEAS.
THE PATIENT REPORTED THAT ON (B)(6) 2024 AN OPEN BILATERAL INGUINAL HERNIA CURE WAS PERFORMED USING THE LICHTENSTEIN TECHNIQUE WITH THE PLACEMENT OF TWO RETRO-APONEUROTIC PROSTHESES. THE PROCEDURE INVOLVED A DORSOL DECUBITUS POSITION UNDER GENERAL ANESTHESIA, INCISION IN THE RIGHT LOWER ABDOMINAL FOLD, OPENING OF THE EXTERNAL OBLIQUE FASCIA, DISSECTION OF A LARGE EXTERNAL OBLIQUE HERNIA, SPERM CORD RELEASE, DETACHMENT OF APONEUROTIC MARGINS, AND THE SPREAD OF A MESH PROSTHESIS ATTACHED TO THE PUBIS, CRURAL ARCH, AND CONJOINED TENDON BY SEPARATE POINTS OF A SUTURE. THE WOUND WAS CLOSED WITH APONEUROTIC CLOSURE, CLOSURE OF THE FASCIA CRIBRIFORMIS, NAROPENINE WALL INFILTRATION, AND NON-ABSORBABLE THREADS ON THE SKIN. POST OPERATIVELY, THE PATIENT EXPERIENCED SEVERE PAIN, INTERNAL BURNS ON THE RIGHT AND LEFT, NEEDLE STROKE SENSATION, AND UNPLEASANT DISCOMFORT IN THE TESTICLES WITH PAIN (SYMPTOMATIC BILATERAL GROIN HERNIA). THE PATIENT ALSO REPORTED FEELING AS IF HAVING BRUISES AND AN IMPRESSION OF HAVING CORRUGATED CARDBOARD INSIDE. THESE SYMPTOMS WERE EXACERBATED WHEN STANDING AND SITTING, LEADING TO WAKING UP AT NIGHT DUE TO NEEDLE STROKE AND BURNS, DIFFICULTY GOING BACK TO SLEEP, AND SOMETIMES SLEEPLESS NIGHTS. THE PATIENT FACED GREAT DIFFICULTY IN SQUATTING, STANDING UP, AND LIFTING LOADS, ALONG W ITH LOSS OF TONE AND INTENSE FATIGUE. PSYCHOLOGICAL CONSEQUENCES INCLUDED ALTERATION OF MOOD, ANXIETY, STRESS, DEPRESSION, AND MORBID IDEAS. THE PATIENT WAS REPORTED TO HAVE DIED BY SUICIDE IN (B)(6) 2025.
THE PATIENT REPORTED THAT ON (B)(6) 2024 AN OPEN BILATERAL INGUINAL HERNIA CURE WAS PERFORMED USING THE LICHTENSTEIN TECHNIQUE WITH THE PLACEMENT OF TWO RETRO-APONEUROTIC PROSTHESES. THE PROCEDURE INVOLVED A DORSOL DECUBITUS POSITION UNDER GENERAL ANESTHESIA, INCISION IN THE RIGHT LOWER ABDOMINAL FOLD, OPENING OF THE EXTERNAL OBLIQUE FASCIA, DISSECTION OF A LARGE EXTERNAL OBLIQUE HERNIA, SPERM CORD RELEASE, DETACHMENT OF APONEUROTIC MARGINS, AND THE SPREAD OF A MESH PROSTHESIS ATTACHED TO THE PUBIS, CRURAL ARCH, AND CONJOINED TENDON BY SEPARATE POINTS OF A SUTURE. THE WOUND WAS CLOSED WITH APONEUROTIC CLOSURE, CLOSURE OF THE FASCIA CRIBRIFORMIS, NAROPENINE WALL INFILTRATION, AND NON-ABSORBABLE THREADS ON THE SKIN. POST OPERATIVELY, THE PATIENT EXPERIENCED SEVERE PAIN, INTERNAL BURNS ON THE RIGHT AND LEFT, NEEDLE STROKE SENSATION, AND UNPLEASANT DISCOMFORT IN THE TESTICLES WITH PAIN (SYMPTOMATIC BILATERAL GROIN HERNIA). THE PATIENT ALSO REPORTED FEELING AS IF HAVING BRUISES AND AN IMPRESSION OF HAVING CORRUGATED CARDBOARD INSIDE. THESE SYMPTOMS WERE EXACERBATED WHEN STANDING AND SITTING, LEADING TO WAKING UP AT NIGHT DUE TO NEEDLE STROKE AND BURNS, DIFFICULTY GOING BACK TO SLEEP, AND SOMETIMES SLEEPLESS NIGHTS. THE PATIENT FACED GREAT DIFFICULTY IN SQUATTING, STANDING UP, AND LIFTING LOADS, ALONG W ITH LOSS OF TONE AND INTENSE FATIGUE. PSYCHOLOGICAL CONSEQUENCES INCLUDED ALTERATION OF MOOD, ANXIETY, STRESS, DEPRESSION, AND MORBID IDEAS.
THE PATIENT REPORTED THAT ON (B)(6) 2024 AN OPEN BILATERAL INGUINAL HERNIA CURE WAS PERFORMED USING THE LICHTENSTEIN TECHNIQUE WITH THE PLACEMENT OF TWO RETRO-APONEUROTIC PROSTHESES. THE PROCEDURE INVOLVED A DORSOL DECUBITUS POSITION UNDER GENERAL ANESTHESIA, INCISION IN THE RIGHT LOWER ABDOMINAL FOLD, OPENING OF THE EXTERNAL OBLIQUE FASCIA, DISSECTION OF A LARGE EXTERNAL OBLIQUE HERNIA, SPERM CORD RELEASE, DETACHMENT OF APONEUROTIC MARGINS, AND THE SPREAD OF A MESH PROSTHESIS ATTACHED TO THE PUBIS, CRURAL ARCH, AND CONJOINED TENDON BY SEPARATE POINTS OF A SUTURE. THE WOUND WAS CLOSED WITH APONEUROTIC CLOSURE, CLOSURE OF THE FASCIA CRIBRIFORMIS, NAROPENINE WALL INFILTRATION, AND NON-ABSORBABLE THREADS ON THE SKIN. POST OPERATIVELY, THE PATIENT EXPERIENCED SEVERE PAIN, INTERNAL BURNS ON THE RIGHT AND LEFT, NEEDLE STROKE SENSATION, AND UNPLEASANT DISCOMFORT IN THE TESTICLES WITH PAIN (SYMPTOMATIC BILATERAL GROIN HERNIA). THE PATIENT ALSO REPORTED FEELING AS IF HAVING BRUISES AND AN IMPRESSION OF HAVING CORRUGATED CARDBOARD INSIDE. THESE SYMPTOMS WERE EXACERBATED WHEN STANDING AND SITTING, LEADING TO WAKING UP AT NIGHT DUE TO NEEDLE STROKE AND BURNS, DIFFICULTY GOING BACK TO SLEEP, AND SOMETIMES SLEEPLESS NIGHTS. THE PATIENT FACED GREAT DIFFICULTY IN SQUATTING, STANDING UP, AND LIFTING LOADS, ALONG W ITH LOSS OF TONE AND INTENSE FATIGUE. PSYCHOLOGICAL CONSEQUENCES INCLUDED ALTERATION OF MOOD, ANXIETY, STRESS, DEPRESSION, AND MORBID IDEAS. IT WAS NOTED THAT THE PATIENT DIED IN (B)(6) 2025.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1665370 | PROGRIP | MESH, SURGICAL, POLYMERIC | FTL | SOFRADIM PRODUCTION SAS | PP1208DR | SYA1851X | 10884521177666 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Male | Other| D | SEE H11. |