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

Model Number TECR1510

Device Problems Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Abdominal Pain (1685); Abscess (1690); Adhesion(s) (1695); Bacterial Infection (1735); Purulent Discharge (1812); Fever (1858); Fistula (1862); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Itching Sensation (1943); Nausea (1970); Pain (1994); Rash (2033); Seroma (2069); Urinary Tract Infection (2120); Vomiting (2144); Discharge (2225); Hernia (2240); Discomfort (2330); Injury (2348); Depression (2361); Impaired Healing (2378); Obstruction/Occlusion (2422); Ascites (2596); Blood Loss (2597); Dysuria (2684); Fluid Discharge (2686); No Code Available (3191); Speech Disorder (4415); Unspecified Tissue Injury (4559); Decreased Appetite (4569); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

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 an incisional hernia.It was reported that after implant, the patient experienced adhesions, bowel obstruction, infection, recurrent incisional hernia, vomiting green emesis, abdominal pain, uti, right lower back and lower abdominal pain, right flank pain, kidney stones, urine culture + for e.Coli, nausea, lysis of adhesions, dilated small bowel with omentum adhered to the anterior abdominal wall, one thick adhesive band to small bowel mesentery leading to obstruction, severe epigastric pain, seroma, fever, abscess, pus lying on mesh, wound remains open (home healthcare visits for dressing changes/wound care), granulation tissue, itchy mild rash around wound, painful urination (diagnosed with dysuria), and mucus type green drainage.Post-operative patient treatment included revision and removal surgery.

Manufacturer Narrative

Additional information: a1, b5, g4.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 an incisional hernia.It was reported that after implant, the patient experienced adhesions, bowel obstruction, infection, recurrent incisional hernia, vomiting green emesis, abdominal pain, uti, right lower back and lower abdominal pain, right flank pain, kidney stones, urine culture + for e.Coli, nausea, lysis of adhesions, dilated small bowel with omentum adhered to the anterior abdominal wall, one thick adhesive band to small bowel mesentery leading to obstruction, severe epigastric pain, seroma, fever, abscess, pus lying on mesh, wound remains open (home healthcare visits for dressing changes/wound care), granulation tissue, itchy mild rash around wound, painful urination (diagnosed with dysuria), and mucus type green drainage.Post-operative patient treatment included revision, additional implants 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.Additional information: b7, g4.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

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 an incisional hernia.It was reported that after implant, the patient experienced adhesions, bowel obstruction, infection, recurrent incisional hernia, vomiting green emesis, abdominal pain, uti, right lower back and lower abdominal pain, right flank pain, kidney stones, urine culture + for e.Coli, nausea, dilated small bowel with omentum adhered to the anterior abdominal wall, one thick adhesive band to small bowel mesentery leading to obstruction, severe epigastric pain, seroma, fever, abscess, pus lying on mesh, wound remains open (home healthcare visits for dressing changes/wound care), granulation tissue, itchy mild rash around wound, painful urination (diagnosed with dysuria), mucus type green drainage, large leukocytes, positive nitrites, hemangioma, pustule, gas and fluid collection, orange serous fluid which grew bacteroides, wound dehiscence, opioid dependence, coughing with blood, mesh had come free at inferior portion, stuttering, nonresponsiveness (felt to be due to narcotics), fibrinous exudate, mild discomfort, and small fistula.Post-operative patient treatment included revision, additional implants, removal surgery, appendectomy, cholecystectomy, prescription medications, iv antibiotics, diagnostic laparoscopy, exploratory laparotomy, lysis of adhesions, drainage of skin and subcutaneous tissue, debridement of wound, abdominal wall reconstruction, and small bowel resection.

Manufacturer Narrative

Additional information: h6 patient codes - c64343 ( gas collection, stuttering, nonresponsiveness, leukocytes, positive nitrites, hemangioma, coughing ).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 an incisional hernia.It was reported that after implant, the patient experienced adhesions, bowel obstruction, infection, recurrent incisional hernia, vomiting green emesis, abdominal pain, uti, right lower back and lower abdominal pain, right flank pain, kidney stones, urine culture + for e.Coli, nausea, dilated small bowel with omentum adhered to the anterior abdominal wall, one thick adhesive band to small bowel mesentery leading to obstruction, severe epigastric pain, seroma, fever, abscess, pus lying on mesh, wound remains open (home healthcare visits for dressing changes/wound care), granulation tissue, itchy mild rash around wound, painful urination (diagnosed with dysuria), mucus type green drainage, large leukocytes, positive nitrites, hemangioma, pustule, gas and fluid collection, orange serous fluid which grew bacteroides, wound dehiscence, opioid dependence, coughing with blood, mesh had come free at inferior portion, stuttering, nonresponsiveness (felt to be due to narcotics), fibrinous exudate, mild discomfort, klebsiella pneumonaie, and small fistula.Post-operative patient treatment included revision, additional implants, removal surgery, appendectomry, cholescystectomy, prescription medications, iv antibiotics, diagnostic laparoscopy, exploratory laparotomy, lysis of adhesions, drainage of skin and subcutaneous tissue, debridement of wound, abdominal wall reconstruction, panniculectomy, admission to hospital, medication, iv f luids, bowel rest, and small bowel resection.

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 Description

The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of an incisional hernia.It was reported that after implant, the patient experienced adhesions, bowel obstruction, infection, recurrent incisional hernia, vomiting green emesis, abdominal pain, uti, right lower back and lower abdominal pain, right flank pain, kidney stones, urine culture + for e.Coli, nausea, dilated small bowel with omentum adhered to the anterior abdominal wall, one thick adhesive band to small bowel mesentery leading to obstruction, severe epigastric pain, seroma, fever, abscess, pus lying on mesh, wound remains open (home healthcare visits for dressing changes/wound care), granulation tissue, itchy mild rash around wound, painful urination (diagnosed with dysuria), mucus type green drainage, large leukocytes, positive nitrites, hemangioma, pustule, gas and fluid collection, orange serous fluid which grew bacteroides, wound dehiscence, opioid dependence, coughing with blood, mesh had come free at inferior portion, stuttering, fibrinous exudate, mild discomfort, klebsiella pneumonaie, depression, loss of appetite, and small fistula.Post-operative patient treatment included revision, additional implants, removal surgery, appendectomy, cholecystectomy, prescription medications, iv antibiotics, diagnostic laparoscopy, exploratory laparotomy, lysis of adhesions, drainage of skin and subcutaneous tis sue, debridement of wound, abdominal wall reconstruction, panniculectomy, admission to hospital, medication, iv fluids, bowel rest, ct-scan, and small bowel resection.Relevant tests/laboratory data: 10oct09: wbc 13.3, alkaline phosphatase 213.Urinalysis showed large leukocytes, + nitrites.Ct scan of abdomen showed postop changes, no acute abnormality.24mar11: ct of abdomen for right-sided flank pain showed nonobstructed ventral hernias containing colon as well as mesenteric fat.Stable 6 cm hemangioma.06jan14 ct of abdomen showed redemonstrations of ventral hernia containing colon without obstruction, and findings compatible with suspected diagnosis of distal small bowel obstruction with transition in right lower/central abdomen.26feb14: abdominal ct showed possible tiny pustule in the ventral subcutaneous tissue of the lower abdomen/pelvis, there may be some thickening of small bowel wall diffusely.16may14: ct of abdomen showed subcutaneous seroma at operative site rather than abscess.17may14: seroma fluid culture grew bacteroides.22may14: abdominal ct showed increasing size of gas and fluid collection anterior abdominal wall compatible with abscess.Measured 5.7 x 12.3 x 20.8 cm.17jun14: abdominal ct showed very small abdominal wall abscess at lower margin of surgical site with maximum measurement of 5.2 cm.17apr2017: h & p noted abdominal ct scan showed previously seen wound dehiscence/open abdominal wall wound and hernia mesh repair changes again seen with underlying bulge of intra-abdominal fat and loops of colon and small bowel.Rim-enhancing area of low central attenuation at left aspect of wound, fluid collection/abscess cannot be excluded.24oct2017: abdominal wound culture + for klebsiella pneumonaie 05apr2019:abdominal ct scan showed evidence of moderate grade small bowel obstruction, probably secondary to adhesions.

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.

• 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: 8456582
• MDR Text Key: 140014527
• Report Number: 9615742-2019-00725
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521180284
• UDI-Public: 10884521180284
• 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,Followup
• Report Date: 06/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2014
• Device Model Number: TECR1510
• Device Catalogue Number: TECR1510
• Device Lot Number: SJB00015
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/31/2023
• Date Device Manufactured: 02/09/2009
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 77 KG
• Patient Ethnicity: Hispanic
• Patient Race: American Indian Or Alaskan Native