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

Model Number	PPDS12
Medical Device Problem Codes	Difficult to Open or Close (2921); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Nausea (1970); Radiation Exposure, Unintended (3164); No Code Available (3191)
Date of Event	03/04/2019
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, post laparoscopic ventral hernia, the patient complained of right sided abdominal pain described as intermittent sharp and stabbing pain that radiated to back, with associated nausea, vomiting and inability to urinate.The patient had a ct scan of the abdomen as a diagnostic test.The results showed a 0.3cm obstructing stone at the right ureterovesical junction with mild.Medication given included: flomax, norco, and zofran.The patient was also hydrated with 2 liters of intravenous fluid and the subject was referred to urology.Some symptoms may be related to post-operative side-effects after hernia repair procedure, though renal stone may be unrelated.The patient is currently recovering.

• 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: 8459890
• Report Number: 9615742-2019-00772
• Device Sequence Number: 2926428
• 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
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/28/2019

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: 03/05/2019
• Initial Report FDA Received Date: 03/28/2019
• 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 Weight: 97