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

Model Number UNKNOWN PARIETEX PRODUCT

Device Problems Loss of or Failure to Bond (1068); Material Erosion (1214); Migration or Expulsion of Device (1395); 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); Erythema (1840); Fistula (1862); Unspecified Infection (1930); Necrosis (1971); Pain (1994); Hernia (2240); Injury (2348); Impaired Healing (2378); Unspecified Tissue Injury (4559)

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 right lower quadrant parastomal and incisional midline hernias.It was reported that after implant, the patient experienced recurrence, infected mesh and subcutaneous tissue, abdominal wound with chronic purulent drainage, large amount of bunched mesh and mesh that was non-adherent to surrounding structures, dense adhesions, fistula, small abscess cavities with necrotic material, pain, erythema at wound site, and exposed mesh and loop of bowel.Post-operative patient treatment included revision surgery, repair of hernia with mesh, excisional debridement of skin, subcutaneous tissue and infected mesh, removal of mesh foreign body and foul smelling flesh, and incision and drainage of abdominal wall.

Event Description

The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of right lower quadrant parastomal and incisional midline hernias.It was reported that after implant, the patient experienced recurrence, infected mesh and subcutaneous tissue, abdominal wound with chronic purulent drainage, large amount of bunched mesh and mesh that was non-adherent to surrounding structures, dense adhesions, fistula, small abscess cavities with necrotic material, pain, herniated left side, erythema at wound site, and exposed mesh and loop of bowel.Post-operative patient treatment included revision surgery, repair of hernia with mesh, excisional debridement of skin, subcutaneous tissue and infected mesh, removal of mesh foreign body and foul smelling flesh, ct scan, fistulogram, medication, and incision and drainage of abdominal wall.

Manufacturer Narrative

Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Manufacturer Narrative

Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• 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 ; 60 middletown ave; 8200 coral sea st ne; mounds view,mn, CT 55112 ; 7635265677
• MDR Report Key: 9127416
• MDR Text Key: 160294461
• Report Number: 9615742-2019-03199
• 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: 05/15/2024

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
• Device Operator: Health Professional
• Device Model Number: UNKNOWN PARIETEX PRODUCT
• Device Catalogue Number: UNKNOWN PARIETEX PRODUCT
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/15/2019
• Initial Date FDA Received: 09/27/2019
• Supplement Dates Manufacturer Received: 05/08/2024; 05/15/2024
• Supplement Dates FDA Received: 05/15/2024; 05/15/2024
• 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): Required Intervention
• Patient Sex: Female
• Patient Weight: 128 KG