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

Model Number PCO2520OS

Device Problems Product Quality Problem (1506); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Purulent Discharge (1812); Fistula (1862); Foreign Body Reaction (1868); Unspecified Infection (1930); Ischemia (1942); Nausea (1970); Pain (1994); Vomiting (2144); Hernia (2240); Injury (2348); Impaired Healing (2378); Obstruction/Occlusion (2422)

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 chronic pain, fistulas, adhesions, and recurrence. Treatment provided for these conditions include revision surgery.

Event Description

The patient¿s attorney alleged a deficiency against the device. The product was used for therapeutic treatment of an incisional hernia. It was reported that after implant, the patient experienced chronic pain , fistulas, adhesions, open wound, infection, recurrence, small bowel obstruction, soft tissue foreign body reaction, nausea, vomiting, abdominal pain, ischemic appendix, open wound and purulent wound bed, protruding mesh, and fistula. Treatment provided for these conditions include revision surgery, small bowel resection, wound vac and mesh explant. The product had been used with an unknown protacker.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• 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
• MDR Report Key: 8061366
• MDR Text Key: 126910880
• Report Number: 9615742-2018-02549
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K050187
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 11/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 08/30/2013
• Device Model Number: PCO2520OS
• Device Catalogue Number: PCO2520OS
• Device Lot Number: PII00220
• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No

Patient Treatment Data

Date Received: 11/12/2018 Patient Sequence Number: 1

Treatment

UNKNOWN PROTACKER