MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS PROGRIP; MESH, SURGICAL, POLYMERIC

Model Number	PP1208DR
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Burning Sensation (2146); Anxiety (2328); Discomfort (2330); Depression (2361); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Death
Additional Manufacturer Narrative
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.
Event or Problem Description
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.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
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.
Event or Problem Description
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.
Event or Problem Description
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.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
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.
Event or Problem Description
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.

• Brand Name: PROGRIP
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• Manufacturer (Section G): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 21807766
• Report Number: 9615742-2025-00324
• Device Sequence Number: 15662199
• Product Code: FTL
• UDI-Device Identifier: 10884521177666
• UDI-Public: (01)10884521177666(17)281231(10)SYA1851X(20)10
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K140941
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 07/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PP1208DR
• Device Catalogue Number: PP1208DR
• Device Lot Number: SYA1851X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2025
• Supplement Date Received by Manufacturer: 04/23/2025; 05/13/2025; 07/15/2025; 07/18/2025
• Initial Report FDA Received Date: 04/09/2025
• Supplement Report FDA Received Date: 04/25/2025; 05/14/2025; 07/18/2025; 07/18/2025
• Date Device Manufactured: 01/24/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Other; Death
• Patient Age: 82 YR
• Patient Sex: Male