MAUDE Adverse Event Report: SOFRADIM PRODUCTION PARIETEX MONO POLY LIGHTWEIGHT MESH; PARIETEX MESH

Catalog Number TCM1510

Device Problems Sticking (1597); Material Integrity Problem (2978)

Patient Problems No Known Impact Or Consequence To Patient (2692); Insufficient Information (4580)

Event Type  malfunction  

Event Description

Procedure: bilateral inguinal hernia repair.According to the reporter: the surgeon felt like the mesh was heavy and felt different immediately upon removing it from the package.She stated that it was sticking together somewhat.She attempted to use it in the patient, but ended up removing it right away.She said that it crumpled up in the patient and was not correct.She asked to have the product returned and the porosity and the weight of this mesh checked.The other two pieces of mesh in that package were normal and she used both in the patient.It was just that one piece that was not of quality.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Supplemental # 3 submitted for an error previously entered into supplemental #2.Supplemental #3 submitted march 18, 2015.

• Brand Name: PARIETEX MONO POLY LIGHTWEIGHT MESH
• Type of Device: PARIETEX MESH
• Manufacturer (Section D): SOFRADIM PRODUCTION; 116 avenue du formans; trevoux F-016 00; FR F-01600
• Manufacturer (Section G): SOFRADIM PRODUCTION; 116 avenue du formans; trevoux ; FR
• Manufacturer Contact: sharon murphy, qa ; 60 middleton ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 3938566
• MDR Text Key: 4597330
• Report Number: 9615742-2014-00097
• Device Sequence Number: 1
• Product Code: OTN
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: TCM1510
• Device Lot Number: SNI0213X
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/25/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/18/2014
• Initial Date FDA Received: 03/04/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1