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

Model Number	PCOPM15
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/07/2018
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, temporary stoma was established due to ileus.Stoma was established again due to transverse colon cancer.Para-stoma hernia occurred and repaired.There was a complaint of recurrent hernia, ileus also occurred.Computed tomography(ct) was performed and noted that the small intestine prolapsed from ileus from the opposite side through the stoma, ileus was confirmed.Hernia was taken care by emergency treatment, when prolapsed again, reoperation was scheduled, ileus was released after ambrosia.Because only ct was performed, it was unable to confirm if there was mesh damage that caused the recurrence.

• Brand Name: PARIETEX
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• MDR Report Key: 8119859
• Report Number: 9615742-2018-02633
• Device Sequence Number: 1710687
• Product Code: FTL
• UDI-Device Identifier: 10884521177758
• UDI-Public: 10884521177758
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K081126
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/30/2018

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: 05/31/2018
• Device Model Number: PCOPM15
• Device Catalogue Number: PCOPM15
• Device Lot Number: PNF0306
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2018
• Initial Report FDA Received Date: 11/30/2018
• 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