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

Model Number	PPDS12
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Nausea (1970); No Code Available (3191)
Date of Event	02/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, post-operative laparoscopic ventral hernia repair, the patient experienced a refractory nausea.The patient was to be discharged at the same day of the procedure, but stayed overnight until the issue was controlled.The patient was given medications and it was reported that nausea was likely induced by the operation.The patient recovered.

• Brand Name: PARIETENE DS
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• MDR Report Key: 8428182
• Report Number: 9615742-2019-00500
• Device Sequence Number: 10823107
• Product Code: FTL
• UDI-Device Identifier: 10884521553446
• UDI-Public: 10884521553446
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/18/2019

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: 04/30/2019
• Device Model Number: PPDS12
• Device Catalogue Number: PPDS12
• Device Lot Number: RRK1387X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2019
• Initial Report FDA Received Date: 03/18/2019
• 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: Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Weight: 98