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

Model Number	TECT1612AFR
Medical Device Problem Codes	Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Abscess (1690); Adhesion(s) (1695); Bacterial Infection (1735); Emotional Changes (1831); Fatigue (1849); Hematoma (1884); Hemorrhage/Blood Loss/Bleeding (1888); Unspecified Infection (1930); Inflammation (1932); Muscle Weakness/Atrophy (1967); Nausea (1970); Necrosis (1971); Pain (1994); Scar Tissue (2060); Seroma (2069); Vomiting (2144); Hernia (2240); Anxiety (2328); Distress (2329); Discomfort (2330); Obstruction/Occlusion (2422); Sleep Dysfunction (2517); Abdominal Cramps (2543); Ascites (2596); Abdominal Distention (2601); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant product: tect1612afl ana ltpy 6x12cm w flap, (lot # sne0471).(b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem 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 infection, infected mesh, abscess, seroma, dense inflammatory reaction with scar formation, adhesions, bladder injury, recurrence, insomnia, pain, traumatic urethral stricture, and suffering.Post-operative patient treatment included revision surgery, removal of mesh, flexible cystourethroscopy, replacement of suprapubic tube, and repair of hernia with mesh.
Additional Manufacturer Narrative
Additional information: b2, b5, g1(mfr contact first name, last name, street1, mfr city, region, postal code, email, phone number), g3, h6 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 or Problem 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 pain, emotional distress, defective device, physical and mental pain, mental anguish, disability, impairment, loss of enjoyment of life, infection, infected mesh, abscess, seroma, dense inflammatory reaction with scar formation, adhesions, bladder injury, recurrence, insomnia, pain, traumatic urethral stricture, and suffering.Post-operative patient treatment included revision surgery, removal of mesh, flexible cystourethroscopy, replacement of suprapubic tube, dissection of bladder from mesh, placement of drain, soft tissue/serosanguinous fluid aspiration, aspiration of seroma, and repair of hernia with mesh.
Additional Manufacturer Narrative
Additional information: a4(weight in lbs.), b7, d6b, e1 (facility name, street 1, city, region, postal code), g3.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 Manufacturer Narrative
Additional information: b5, b6, g3 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 or Problem 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 infection, infected mesh, abscess, seroma, dense inflammatory reaction with scar formation, adhesions, bladder injury, recurrence, insomnia, pain, traumatic urethral stricture, andsuffering.Post-operative patient treatment included revision surgery, removal of mesh, flexible cystourethroscopy, replacement of suprapubic tube, soft tissue/serosanguinous fluid aspiration, and repair of hernia with mesh.
Additional Manufacturer Narrative
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 or Problem 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 pain, emotional distress, defective device, physical and mental pain, mental anguish, disability, impairment, loss of enjoyment of life, infection, infected mesh, abscess, seroma, dense inflammatory reaction with scar formation, adhesions, bladder injury, recurrence, insomnia, pain, traumatic urethral stricture, anxiety, emotional distress, and suffering.Post-operative patient treatment included revision surgery, removal of mesh, flexible cystourethroscopy, replacement of suprapubic tube, dissection of bladder from mesh, placement of drain, soft tissue/serosanguinous fluid aspiration, aspiration of seroma, ultrasound imaging, and repair of hernia with mesh.Relevant tests/laboratory data: 10 jan 2020: ultrasound showed a large 5.3 x 12.5 x 1.7 cm intra-abdominal seroma.
Additional Manufacturer Narrative
Additional info: a4, a5b, b2, b5, b6, b7, & h6 (patient codes, ime e2402: ileus, induration).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 or Problem 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 pain, emotional distress, defective device, physical and mental pain, mental anguish, disability, impairment, loss of enjoyment of life, infection, infected mesh, abscess, seroma, dense inflammatory reaction with scar formation, adhesions, bladder injury, recurrence, insomnia, pain, traumatic urethral stricture, anxiety, emotional distress, suffering, dilated small bowel loops, fluid collection, necrotic tissue, hematoma, positive for klebsiella pneumonaie; staphylococcus epidermidis; cutibacterium acnes, rectus diastases, gaseous distention, ileus, small bowel obstruction, vomiting, weakness, fatigue, nausea, abdominal pain, blood fluid, persistent abdominal bloating, abdominal cramping, tightness/pain due to seroma, induration, & scar tissue.Post-operative patient treatment included revision surgery, removal of mesh, flexible cystourethroscopy, replacement of suprapubic tube, dissection of bladder from mesh, placement of drain, soft tissue/serosanguinous fluid aspiration, aspiration of seroma, ultrasound imaging, repair of hernia with mesh, ct scan, iv fluids, medication, hospitalization, ct guided drain procedure, picc line placement, iv antibiotics, urethroplasty, ng tube placement, pain medication, & sclerotherapy of the cavity.

• Brand Name: PARIETEX
• 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 ; 5920 longbow drive; 8200 coral sea st ne; mounds view,mn, CT 55112 ; 7635265677
• MDR Report Key: 11348915
• Report Number: 9615742-2021-00379
• Device Sequence Number: 4117626
• Product Code: FTL
• UDI-Device Identifier: 10884521179950
• UDI-Public: 10884521179950
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K982532
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 03/09/2023

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 Expiration Date: 05/30/2018
• Device Model Number: TECT1612AFR
• Device Catalogue Number: TECT1612AFR
• Device Lot Number: SNF0289
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/03/2021
• Supplement Date Received by Manufacturer: 02/03/2021; 03/10/2021; 12/15/2021; 02/08/2023; 03/01/2023
• Initial Report FDA Received Date: 02/19/2021
• Supplement Report FDA Received Date: 03/05/2021; 03/25/2021; 01/03/2022; 02/15/2023; 03/09/2023
• Date Device Manufactured: 06/20/2013
• 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 SECTION H10
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Disability
• Patient Sex: Male
• Patient Weight: 97 KG
• Patient Race: White