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

Model Number	PPDS2015
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Hematoma (1884); Pain (1994); Numbness (2415)
Date of Event	06/28/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem 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
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• MDR Report Key: 8928869
• Report Number: 9615742-2019-02879
• Device Sequence Number: 16221103
• Product Code: FTL
• UDI-Device Identifier: 10884521553477
• UDI-Public: 10884521553477
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K163212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2019
• Initial Report FDA Received Date: 08/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Weight: 130