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

Model Number	PPDS2520
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Nausea (1970); Pain (1994); No Code Available (3191)
Date of Event	09/19/2018
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, following a laparoscopic hernia repair for incisional midline hernia repair, the patient presented with pain and nausea.Ct scans and x-ray imaging was done and showed imaging consistent with post-operative ileus.The patient was admitted and bowel rest was provided and the patient was treated with intravenous fluid hydration along with medications for the pain and nausea.
Event or Problem Description
According to the reporter, following a ventral herbnia repair, the patient was presented with symptoms and imaging consistent with a post-operative ileus.The patient was admitted for bowel rest, intravenous fluid hydration, and treatment for pain and nausea.Diagnostic procedures performed included ct and xray.Specific medications were given.Other action taken included bowel rest and intravenous fluid hydration.The patient was not hospitalized for more than 24 hours.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• 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: 7975854
• Report Number: 9615742-2018-02319
• Device Sequence Number: 16457462
• Product Code: FTL
• UDI-Device Identifier: 10884521553484
• UDI-Public: 10884521553484
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2019

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: 03/31/2019
• Device Model Number: PPDS2520
• Device Catalogue Number: PPDS2520
• Device Lot Number: RRJ1059X
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/21/2018
• Supplement Date Received by Manufacturer: 07/01/2019
• Initial Report FDA Received Date: 10/17/2018
• Supplement Report FDA Received Date: 07/18/2019
• 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: 54 YR
• Patient Weight: 94