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

Model Number UNKNOWN PARIETEX

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Adhesion(s) (1695); Adult Respiratory Distress Syndrome (1696); Low Blood Pressure/ Hypotension (1914); Pain (1994); Sepsis (2067); Hernia (2240); Injury (2348); Obstruction/Occlusion (2422); No Code Available (3191)

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 and sepsis. Post-operative patient treatment included multiple surgical revisions.

Event Description

The patient¿s attorney alleged a deficiency against the device. The product was used for therapeutic treatment of a hiatal hernia. It was reported that after implant, the patient experienced recurrence, adhesions, dysmotility of distal esophagus, gastroparesis, fibrous food in gastric fundus, hypotension, respiratory distress syndrome, pain, obstructive swallowing, diaphragmatic defect, and sepsis. Post-operative patient treatment included multiple surgical revisions, laparoscopic reduction and repair of incarcerated recurrent para-esophageal hernia with inter-thoracic stomach, vasopressor support, and intubation.

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. (b)(4). If information is provided in the future, a supplemental report will be issued.

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. 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 hiatal hernia. It was reported that after implant, the patient experienced recurrence, adhesions and sepsis. Post-operative patient treatment included multiple surgical revisions, laparoscopic reduction and repair of incarcerated recurrent para-esophageal hernia with inter-thoracic stomach.

• Brand Name: PARIETEX MESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• MDR Report Key: 8183397
• MDR Text Key: 130976170
• Report Number: 9615742-2018-02874
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: UNKNOWN PARIETEX
• Device Catalogue Number: UNKNOWN PARIETEX
• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No

Patient Treatment Data

Date Received: 12/20/2018 Patient Sequence Number: 1