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

Model Number TECT1612AR

Device Problems Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Abscess (1690); Adhesion(s) (1695); Bacterial Infection (1735); Purulent Discharge (1812); Emotional Changes (1831); Fatigue (1849); Foreign Body Reaction (1868); Gangrene (1873); Hematoma (1884); Unspecified Infection (1930); Inflammation (1932); Muscle Weakness (1967); Necrosis (1971); Pain (1994); Scar Tissue (2060); Scarring (2061); Sepsis (2067); Swelling (2091); Weakness (2145); Discharge (2225); Peritonitis (2252); Injury (2348); Malaise (2359); Deformity/ Disfigurement (2360); Impaired Healing (2378); Ascites (2596); Abdominal Distention (2601); Bowel Perforation (2668); Fluid Discharge (2686); No Code Available (3191); Nodule (4551); Unspecified Tissue Injury (4559); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Death  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

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 implant, the patient experienced chronic pain, scrotal abscess and infection.Post-operative patient treatment included revision and removal surgery.

Manufacturer Narrative

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.Concomitant product: ethicon physio (umbilical) 10cm x 15 cm; tect1612al(lot#: sml00403); 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.

Event Description

The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of bilateral inguinal hernias.It was reported that after implant, the patient experienced chronic pain, scrotal abscess, open wound, and infection.Post-operative patient treatment included revision surgery, drainage, drainage debridement, left inguinal abscess and preperitoneal abscess drainage and debridement, pelvic/suprapubic right preperitoneal abscess drainage and debridement, wound vac, removed infected inguinal mesh, and removal surgery.

Event Description

The patient¿s attorney alleged a deficiency against the device.The product was used for laparoscopic therapeutic treatment of bilateral inguinal hernias.It was reported that after implant, the patient experienced chronic pain, scrotal abscess, open wound, hematoma, abscess, fluid collection, leukosytosis, mssa methicillin sensitive staphylococcus aureus, murky brown pus, hydrocele, fournier¿s gangrene, weakness, tiredness, non-tender firm hard mass, necrotic tissue, sinus tract, inflammation, firm indurated inflamed tissue, swelling, purulent material, drainage, foreign body infection, mesh poorly incorporated, malaise, scarring, fibrinous exudate, loculations, bulging, sepsis/systemic inflammatory response syndrome, and infection.Post-operative patient treatment included revision surgery, left inguinal abscess and preperitoneal abscess drainage and debridement, pelvic/suprapubic right preperitoneal abscess drainage and debridement, wound vac, removed infected inguinal mesh, incision and drainage of scrotum, evacuation of scrotal hematoma, medications, antibiotics, wound packed, icu, drain placement, debridement of necrotic tissue, and irrigation of scrotal abscess.

Manufacturer Narrative

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.H6:patient code-c64343( leukosytosis, hydrocele, sinus tract, induration, loculations, non-tender firm hard mass).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.

Manufacturer Narrative

Additional info: b2 (outcome attributed to adverse event, date of death), b5, d8, e1, g1, h1, h6 (all codes; e2402: leukocytosis, hy drocele, sinus tract, induration, loculations, pneumoperitoneum) complaint reportability has been reassessed and is now reportable as a death.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.

Event Description

The patient¿s attorney alleged a deficiency against the device.The product was used for laparoscopic therapeutic treatment of bilateral inguinal hernias.It was reported that after implant, the patient experienced physical deformity, defective device, disability, impairment, loss of enjoyment of life, disfigurement, mental anguish, adherent tissue, bowel perforation, pneumoperitoneum, peritonitis, chronic pain, scrotal abscess, open wound, hematoma, abscess, fluid collection, leukocytosis, mssa (methicillin sensitive staphylococcus aureus), murky brown pus, hydrocele, fournier¿s gangrene, weakness, tiredness, non-tender firm hard mass, necrotic tissue, sinus tract, inflammation, firm indurated inflamed tissue, swelling, purulent material, drainage, foreign body infection, mesh poorly incorporated, malaise, scarring, fibrinous exudate, loculations, bulging, sepsis/systemic inflammatory response syndrome, infection, and death.Post-operative patient treatment included ct scan, intubation, right hemicolectomy with end ileostomy, revision surgery, left inguinal abscess and preperitoneal abscess drainage and debridement, pelvic/suprapubic right preperitoneal abscess drainage and debridement, wound vac, removed infected inguinal mesh, incision and drainage of scrotum, evacuation of scrotal hematoma, medications, antibiotics, wound packed, icu, drain placement, debridement of necrotic tissue, and irrigation of scrotal abscess.Information received indicates the patient is deceased.No information was provided regarding the circumstances of expiration.

• Brand Name: PARIETEX
• Type of Device: 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, CT 55112 ; 7635265677
• MDR Report Key: 8414804
• MDR Text Key: 138632090
• Report Number: 9615742-2019-00448
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521179967
• UDI-Public: 10884521179967
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K982532
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2017
• Device Model Number: TECT1612AR
• Device Catalogue Number: TECT1612AR
• Device Lot Number: SMG00142
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/04/2023
• Date Device Manufactured: 07/17/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN SECURETAC TACKER.
• Patient Outcome(s): Death; Disability; Hospitalization; Required Intervention
• Patient Sex: Male