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

Model Number TECT1510AL

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

Patient Problems Abdominal Pain (1685); Abscess (1690); Adhesion(s) (1695); Erosion (1750); Cellulitis (1768); Fistula (1862); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Seroma (2069); Discharge (2225); Hernia (2240); Urinary Frequency (2275); Injury (2348); Fasciitis (2375); Impaired Healing (2378); Weight Changes (2607); Dysuria (2684); Fluid Discharge (2686); No Code Available (3191); Constipation (3274); Unspecified Tissue Injury (4559)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical product: tect1510ar anat rt std py 15x10cm (product id: tect1510ar; lot#: 22263tct15ad).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 inguinal hernias.It was reported that after the implant, the patient experienced infection and pain.Post-operative patient treatment included revision surgery.

Manufacturer Narrative

Additional information: h6-patient code: c64343(myositis,osteomyelitis bilateral pubic bodies ,cystitis,colonic malignancy,nocturia,tissue rock hard).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 a inguinal hernias.It was reported that after the implant, the patient experienced infection, pain, abscess, inflammatory phlegmon, myositis, fasciitis, osteomyelitis bilateral pubic bodies, cellulitis, mesh erosion, fistula, cystitis, abdominal pain, weight loss, colonic malignancy, constipation, increased urinary frequency, nocturia, dysuria, adhesions, tissues rock hard/woody, discharge, and open wound.Post-operative patient treatment included wound vac, revision surgery, admission to hospital, drainage of abscess, wound care, wound vac, medication, extensive adhesiolysis, drain placement, extensive debridement of preperitoneal space, removed all seen tacks, wounds irrigated, wound edges debrided, and mesh removal of one of the two devices.

Event Description

The patient¿s attorney alleged a deficiency against the device.The product was used for laparoscopic therapeutic treatment of a inguinal hernias.It was reported that after the implant, the patient experienced infection, pain, abscess, inflammatory phlegmon, myositis, fasciitis, osteomyelitis bilateral pubic bodies, cellulitis, mesh erosion, fistula, cystitis, abdominal pain, weight loss, colonic malignancy, constipation, increased urinary frequency, nocturia, dysuria, adhesions, tissues rock hard/woody, discharge, and open wound.Post-operative patient treatment included wound vac, revision surgery, admission to hospital, drainage of abscess, wound care, vac exchange, medication, extensive adhesiolysis, drain placement, extensive debridement of preperitoneal space, removed all seen tacks, wounds irrigated, wound edges debrided, and mesh removal of one of the two devices, mri of abdomen/pelvis showed multiloculated complex fluid collections, cystogram, ct scan, fluid collections, antibiotics, exploratory laparotomy, and mesh removed except where adhered to sigmoid colon.Relevant tests/laboratory data: 17 dec 2014: mri of abdomen/pelvis showed multiloculated complex fluid collections consistent with abscesses with surrounding enhancing inflammatory phlegmon, myositis and fasciitis.Findings consistent with osteomyelitis bilateral pubic bodies.Extensive subcutaneous inflammation/cellulitis throughout lower abdomen, inguinal region and proximal thighs, l>r.Cystogram noted bladder wall irregularities of bladder concerning for mesh erosion into the bladder 18 dec 2015: ct scan of abdomen/pelvis showed multiple loculated rim enhanced fluid collections within the lower abdomen and pelvis suggesting multifocal abscesses.Enhanced tissue contiguous to markedly enhanced tissue within lower abdominal wall and subcutaneous tissues suggesting fistulous communication.Diffuse bladder wall thickening suggesting cystitis.

Manufacturer Narrative

Additional code 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: h6 (patient codes).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.

Event Description

The patient¿s attorney alleged a deficiency against the device.The product was used for laparoscopic therapeutic treatment of a inguinal hernias.It was reported that after the implant, the patient experienced recurrence, seroma, infection, pain, abscess, inflammatory phlegmon, myositis, fasciitis, osteomyelitis bilateral pubic bodies, cellulitis, mesh erosion, fistula, cystitis, abdominal pain, weight loss, colonic malignancy, constipation, increased urinary frequency, nocturia, dysuria, adhesions, tissues rock hard/woody, discharge, and open wound.Post-operative patient treatment included wound vac, revision surgery, admission to hospital, drainage of abscess, wound care, vac exchange, medication, extensive adhesiolysis, drain placement, extensive debridement of preperitoneal space, removed all seen tacks, wounds irrigated, wound edges debrided, and mesh removal of one of the two devices, mri of abdomen/pelvis showed multiloculated complex fluid collections, cystogram, ct scan, fluid collections, antibiotics, exploratory laparotomy, and mesh removed except where adhered to sigmoid colon.

• 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 ; 60 middletown ave.; 8200 coral sea st ne; mounds view,mn, CT 55112 ; 7635265677
• MDR Report Key: 10233781
• MDR Text Key: 197610319
• Report Number: 9615742-2020-01414
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521180321
• UDI-Public: 10884521180321
• 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: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2007
• Device Model Number: TECT1510AL
• Device Catalogue Number: TECT1510AL
• Device Lot Number: 22185TCT15AG
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/10/2023
• 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: SEE SECTION H10.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 54 KG
• Patient Race: White