MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS UNKNOWN PARIETEX PRODUCT; Mesh, surgical, polymeric

Model Number UNKNOWN PARIETEX PRODUCT

Device Problems Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001); Material Split, Cut or Torn (4008)

Patient Problems Adhesion(s) (1695); Erosion (1750); Fistula (1862); Unspecified Infection (1930); Pain (1994); Perforation (2001); Seroma (2069); Hernia (2240); Discomfort (2330); Impaired Healing (2378); Obstruction/Occlusion (2422); Fluid Discharge (2686); Nodule (4551); Unspecified Tissue Injury (4559); 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 laparoscopic therapeutic treatment of a ventral hernia.It was reported that after the implant, the patient experienced infected mesh, migrated mesh, mesh erosion, adhesions, enterotomy, serosanguineous fluid, recurrence, open wound, fistula, discomfort, mass, serous fluid, and obstructions.Post-operative patient treatment included revision surgery, removal of mesh, debridement of exposed mesh, lysis of adhesions, hernia repair with sutures, revision of mesh, evacuation of serosanguineous fluid, wound debridement, repair of enterotomies, small bowel resection, hernia repair with new mesh, serous fluid were liberated, and dissection of mesh.

Event Description

The patient¿s attorney alleged a deficiency against the device.The product was used for laparoscopic therapeutic treatment of a ventral hernia.It was reported that after the implant, the patient experienced infected mesh, migrated mesh, mesh erosion, adhesions, enterotomy, serosanguineous fluid, recurrence, open wound, fistula, discomfort, mass, serous fluid, pain, seroma, exposed mesh, hernia defect through mesh, and obstructions.Post-operative patient treatment included revision surgery, removal of mesh, debridement of exposed mesh, lysis of adhesions, hernia repair with sutures, revision of mesh, evacuation of serosanguineous fluid, wound debridement, repair of enterotomies, small bowel resection, hernia repair with new mesh, serous fluid were liberated, and dissection of mesh.

Manufacturer Narrative

Additional information: 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 Description

The patient¿s attorney alleged a deficiency against the device.The product was used for laparoscopic therapeutic treatment of a ventral hernia.It was reported that after the implant, the patient experienced perforation, incarcerated hernia, infected mesh, migrated mesh, mesh erosion, adhesions, enterotomy, serosanguineous fluid, recurrence, open wound, fistula, discomfort, mass, serous fluid, pain, seroma, exposed mesh, hernia defect through mesh, and obstructions.Post-operative patient treatment included medication, blake drains, antibiotics, revision surgery, removal of mesh, debridement of exposed mesh, lysis of adhesions, hernia repair with sutures, revision of mesh, evacuation of serosanguineous fluid, wound debridement, repair of enterotomies, small bowel resection, hernia repair with new mesh, serous fluid were liberated, and dissection of mesh.

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.

• Brand Name: UNKNOWN PARIETEX PRODUCT
• 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: 11861160
• MDR Text Key: 251930878
• Report Number: 9615742-2021-01351
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 11/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN PARIETEX PRODUCT
• Device Catalogue Number: UNKNOWN PARIETEX PRODUCT
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/02/2022
• 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: UNKNOWN PROTACK (LOT#UNKNOWN); UNKNOWN PROTACK (LOT#UNKNOWN)
• Patient Outcome(s): Required Intervention
• Patient Sex: Female
• Patient Weight: 122 KG
• Patient Race: White