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

Model Number TET3030

Device Problems Migration or Expulsion of Device (1395); Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Abscess (1690); Adhesion(s) (1695); Erosion (1750); Purulent Discharge (1812); Emotional Changes (1831); Fistula (1862); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Inflammation (1932); Muscle Weakness (1967); Necrosis (1971); Pain (1994); Hernia (2240); Impaired Healing (2378); Ascites (2596); Fluid Discharge (2686); Foreign Body In Patient (2687); Cancer (3262); Nodule (4551); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: pco3020 comp 3dpy 30x20cm no thr (lot# b22148pco32) (b)(4).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 incisional hernia.It was reported that after the implant, the patient experienced unincorporated mesh, which was opened, and this appeared to be into the peritoneal cavity, infection/infected mesh, indurated tissue beneath it appeared to be a rind over the surface of the bowel, chronic granulation tissue, purulent material, adhesions, draining wound, mesh erosion, fistulous communication to the small bowel, bowel injury, murky fluid, attenuated tissue, foreign bodies in the anterior abdominal wall, large squamous cell cancer, recurrence, densely adhered mass, bowel showed less tendency to eviscerate from the abdominal cavity, abscess, open wound, mesh fragmented, area of fluctuance, chronic serositis, hemorrhage, necrosis, chronic draining tracts, fistula, and fluid collection.Post-operative patient treatment included revision surgery, excision of extensive dissection of the viscera, free this densely adherent mass from the anterior abdominal wall, adhesiolysis, excision of segment of bowel/fistula, wound vac, excision of mesh, excision of foreign bodies in the anterior abdominal wall, full-thickness excision of skin,/muscle/fascia, takedown of enterocutaneous fistula, small bowel resection with primary anastomosis, partial colectomy with end colostomy, partial omentectomy, excision of large squamous cell cancer, hernia repair with new mesh, abdominal irrigation/debridement, change of vacuum dressings, abdominal washout, incision/drainage of abscess, wound was copiously irrigated/debrided and packed with saline-soaked gauze, placement of drains, admission to hospital, and removal/irrigation of purulent material.

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 a incisional hernia.It was reported that after the implant, the patient experienced pain, unincorporated mesh, which was opened, and this appeared to be into the peritoneal cavity, infection/infected mesh, indurated tissue beneath it appeared to be a rind over the surface of the bowel, chronic granulation tissue, purulent material, adhesions, draining wound, mesh erosion, fistulous communication to the small bowel, bowel injury, murky fluid, attenuated tissue, foreign bodies in the anterior abdominal wall, large squamous cell cancer, recurrence, densely adhered mass, bowel showed less tendency to eviscerate from the abdominal cavity, abscess, open wound, mesh fragmented, area of fluctuance, chronic serositis, hemorrhage, necrosis, chronic draining tracts, fistula, and fluid collection.Post-operative patient treatment included revision surgery, excision of extensive dissection of the viscera, free this densely adherent mass from the anterior abdominal wall, adhesiolysis, excision of segment of bowel/fistula, wound vac, excision of mesh, excision of foreign bodies in the anterior abdominal wall, full-thickness excision of skin,/muscle/fascia, takedown of enterocutaneous fistula, small bowel resection with primary anastomosis, partial colectomy with end colostomy, partial omentectomy, excision of large squamous cell cancer, hernia repair with new mesh, abdominal irrigation/debridement, change of vacuum dressings, abdominal washout, incision/drainage of abscess, wound was copiously irrigated/debrided and packed with saline-soaked gauze, placement of drains, admission to hospital, and removal/irrigation of purulent material.

Event Description

The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of a incisional hernia.It was reported that after the implant, the patient experienced sinus tract, inflammation, humiliation, pain, unincorporated mesh, which was opened, and this appeared to be into the peritoneal cavity, infection/infected mesh, indurated tissue beneath it appeared to be a rind over the surface of the bowel, chronic granulation tissue, purulent material, adhesions, draining wound, mesh erosion, fistulous communication to the small bowel, bowel injury, murky fluid, attenuated tissue, foreign bodies in the anterior abdominal wall, large squamous cell cancer, recurrence, densely adhered mass, bowel showed less tendency to eviscerate from the abdominal cavity, abscess, open wound, mesh fragmented, area of fluctuance, chronic serositis, hemorrhage, necrosis, chronic draining tracts, fistula, and fluid collection.Post-operative patient treatment included wearing bags and dressings on abdomen for more than 18 years, use of drain, blake drain, revision surgery, excision of extensive dissection of the viscera, free this densely adherent mass from the anterior abdominal wall, adhesiolysis, excision of segment of bowel/fistula, wound vac, excision of mesh, excision of foreign bodies in the anterior abdominal wall, full-thickness excision of skin,/muscle/fascia, takedown of enterocutaneous fistula, small bowel resection with primary anastomosis, partial colectomy with end colostomy, partial omentectomy, excision of large squamous cell cancer, hernia repair with new mesh, abdominal irrigation/debridement, change of vacuum dressings, abdominal washout, incision/drainage of abscess, wound was copiously irrigated/debrided and packed with saline-soaked gauze, placement of drains, admission to hospital, and removal/irrigation of purulent material.

Manufacturer Narrative

Additional info: a4, b5, b7, g1, g3, h6 (added patient codes, ime e2402: "indurated tissue, mass, area of fluctuance, serositis, sinus tract").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.

• 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 ; 5920 longbow drive; 8200 coral sea st ne; mounds view,mn, CO 55112 ; 7635265677
• MDR Report Key: 12029274
• MDR Text Key: 258729983
• Report Number: 9615742-2021-01540
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521180185
• UDI-Public: 10884521180185
• 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
• Report Date: 12/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/04/2005
• Device Model Number: TET3030
• Device Catalogue Number: TET3030
• Device Lot Number: 99348TT3
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/07/2022
• 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: 159 KG