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

Model Number TCM4530

Device Problems Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Hernia (2240); Discomfort (2330); Abdominal Distention (2601); Unspecified Tissue Injury (4559)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical product: surgimend mesh 16x20 cm (product id: unknown, lot number: 1606042).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 an incisional hernia.It was reported that after implant, the patient experienced recurrence, disruption mesh, chronic pain, bulge, and discomfort.Post-operative patient treatment included hernia repair with new mesh and mesh re-secured.

• Brand Name: PARIETEX
• 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: lisa hernandez ; 60 middletown ave; north haven, CT 06473 ; 2034925563
• MDR Report Key: 11090218
• MDR Text Key: 224180694
• Report Number: 9615742-2020-02943
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521178939
• UDI-Public: 10884521178939
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090858
• 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
• Report Date: 12/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Model Number: TCM4530
• Device Catalogue Number: TCM4530
• Device Lot Number: SOK0472X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/02/2020
• Date Device Manufactured: 12/01/2014
• 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