MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN SYMBOTEX; MESH, SURGICAL, POLYMERIC

Model Number	SYM2012EF
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Adhesion(s) (1695); Obstruction/Occlusion (2422); No Code Available (3191)
Date of Event	12/05/2019
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 a laparoscopic treatment of an umbilical hernia with intraperitoneal mesh inlay, there were pronounced adhesions of small intestine noted at the net with consecutive intestinal obstruction.The patient had to undergo an emergency surgery, wherein the procedure started laparoscopically, and was converted to open surgery due to unusual extent of adhesions.

• Brand Name: SYMBOTEX
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 10494366
• Report Number: 1219930-2020-03672
• Device Sequence Number: 14368216
• Product Code: FTL
• UDI-Device Identifier: 10884521190443
• UDI-Public: 10884521190443
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K131969
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/04/2020

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 Model Number: SYM2012EF
• Device Catalogue Number: SYM2012EF
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2020
• Initial Report FDA Received Date: 09/04/2020
• 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: 48 YR