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

Model Number PNP6X3

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

Patient Problems Abscess (1690); Purulent Discharge (1812); Erythema (1840); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Staphylococcus Aureus (2058); Swelling (2091); Discharge (2225); Hernia (2240); Discomfort (2330); Injury (2348); Impaired Healing (2378)

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 post-op swelling, erythremia in skin overlying left groin, acute and chronic inflammation, infected mesh, severe pain and discomfort.Post-operative patient treatment included revision surgery.

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 bilateral inguinal hernia.It was reported that after implant, the patient experienced post-op swelling, erythremia in skin overlying left groin, acute and chronic inflammation, infected mesh, severe pain, recurrence, open wound, draining, abscess, staph infection, purulent fluid, and discomfort.Post-operative patient treatment included revision surgery, explantation of mesh, and repair of hernia.

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.

• Brand Name: PARIETEX
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• MDR Report Key: 8134472
• MDR Text Key: 129370415
• Report Number: 9615742-2018-02683
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 20884521176420
• UDI-Public: 20884521176420
• Combination Product (y/n): N
• PMA/PMN Number: K101519
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 01/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2018
• Device Model Number: PNP6X3
• Device Catalogue Number: PNP6X3
• Device Lot Number: SNG0276
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PNP8X3(LOT#: SOI0163X)
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 83