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

Model Number PCO9X

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

Patient Problems Adhesion(s) (1695); Diarrhea (1811); Nausea (1970); Pain (1994); Hernia (2240); Discomfort (2330); Injury (2348); Abdominal Distention (2601); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 laparoscopic therapeutic treatment of an incisional hernia.It was reported that after implant, the patient experienced adhesions, recurrence, severe pain, suffering, nausea, diarrhea, popping sensation, bulge, diastasis recti, and discomfort.Post-operative patient treatment included revision surgery, hernia repair with new mesh, creation of bilateral myofascial advancement flaps with posterior component separation (tars), creation of fasciocutaneous flaps with anterior component separation (ramirez), placement of drain, hernia sac removed, and mesh removal.

• 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: 10774831
• MDR Text Key: 214317756
• Report Number: 9615742-2020-02455
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521179875
• UDI-Public: 10884521179875
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110815
• 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: 11/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2015
• Device Model Number: PCO9X
• Device Catalogue Number: PCO9X
• Device Lot Number: PNF0040
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/14/2020
• 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
• Treatment: UNKNOWN ABSORBATACK (LOT# UNKNOWN)
• Patient Outcome(s): Required Intervention
• Patient Weight: 100