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

Model Number PCO2520

Device Problems Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Abscess (1690); Adhesion(s) (1695); Fistula (1862); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Perforation (2001); Renal Failure (2041); Seroma (2069); Hernia (2240); Impaired Healing (2378); Obstruction/Occlusion (2422); Fluid Discharge (2686); Cramp(s) /Muscle Spasm(s) (4521); 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 therapeutic treatment of a hernia.It was reported that after implant, the patient experienced recurrence, infection, adhesions, abscess, fistula, and organ damage.Post-operative patient treatment included small bowel resection, revision surgery/debridement, mesh removal, wound vac, and mesh failure.

Manufacturer Narrative

Additional information: h6.(ime, imf codes, ime e2402: hearing loss, bad eyesight).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.

Event Description

The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of a hernia.It was reported that after implant, the patient experienced recurrence, infection, adhesions, abscess, fistula, organ damage, mesh failure, small bowel perforation, leakage of succus entericus, non-healing wound, pain, inflammation, obstructions, seroma, kidney failure from infection, cramping, hearing loss, bad eyesight.Post-operative patient treatment included small bowel resection, bowel removal, revision surgery/debridement, mesh removal, mesh revision, wound vac, lysis of adhesions, hernia repair with mesh, diagnostic laparoscopy, abdominal washout, abdomen pack opened, removal of sinus tract, panniculectomy, ileostomy, medication.

Manufacturer Narrative

Correction: h6 (ime code).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: MESH SOFRADIM - PARIETEX¿ COMPOSITE MESH
• 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: 14188515
• MDR Text Key: 289891000
• Report Number: 9615742-2022-00354
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040998
• 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: 05/27/2024

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 Expiration Date: 12/31/2012
• Device Model Number: PCO2520
• Device Catalogue Number: PCO2520
• Device Lot Number: PIA00248
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/06/2022
• Initial Date FDA Received: 04/22/2022
• Supplement Dates Manufacturer Received: 05/01/2024; 05/22/2024
• Supplement Dates FDA Received: 05/15/2024; 05/28/2024
• Date Device Manufactured: 01/19/2008
• 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; Life Threatening
• Patient Sex: Female
• Patient Weight: 93 KG