MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS PARIETENE¿ DS COMPOSITE MESH; MESH, SURGICAL, POLYMERIC

Model Number PPDS2015

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

Patient Problems Abdominal Pain (1685); Hematoma (1884); Pain (1994); Numbness (2415)

Event Date 06/28/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

According to the reporter, following a laparoscopic ventral hernia procedure, the patient experienced continual numbness around his umbilicus, rectus sheath hematoma and intermittent abdominal pain.The patient was treated with iv pain medication that was then transitioned to oral medication.On first month follow up visit, the patient reports that pain is still ongoing.

• Brand Name: PARIETENE¿ DS COMPOSITE MESH
• 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: 8928869
• MDR Text Key: 155481679
• Report Number: 9615742-2019-02879
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521553477
• UDI-Public: 10884521553477
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163212
• 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: 08/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2019
• 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: PPDS2015
• Device Catalogue Number: PPDS2015
• Device Lot Number: RSF1067X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/01/2019
• Date Device Manufactured: 06/25/2018
• 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
• Patient Age: 67 YR
• Patient Weight: 130