MAUDE Adverse Event Report: ASPIDE MEDICAL SURGIMESH WN; MESH, SURGICAL, POLYMERIC

Model Number SURGIMESH WN

Device Problem Contamination (1120)

Patient Problem Unspecified Infection (1930)

Event Date 03/02/2017

Event Type  Injury  

Event Description

The surgeon implanted a surgimesh wn tealfil-8 using only the plug portion of the product to repair the patient's inguinal hernia on (b)(6) 2016.The wn tealfil-8 was taken from a sterile package in the operating field.Antibiotics were initiated for the patient on (b)(6) 2017 due to a developing infection.The surgeon removed the mesh on (b)(6) 2017.The surgeon notified the distributor of this event on (b)(6) 2017.This case is one (1) of five (5) removals for infection out of approximately 530 open inguinal repairs done by the surgeon using the wn tealfil-8 mesh.

• Brand Name: SURGIMESH WN
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ASPIDE MEDICAL; 246 allee lavoisier; la talaudiere, 42350 ; FR 42350
• Manufacturer (Section G): ASPIDE MEDICAL; 246 allee lavoisier; la talaudiere, 42350 ; FR 42350
• Manufacturer Contact: sid ahmed tadjer ; 246 allee lavoisier; la talaudiere, 42350 ; FR 42350
• MDR Report Key: 7325751
• MDR Text Key: 101954982
• Report Number: 3006617478-2018-00002
• Device Sequence Number: 1
• Product Code: FTM
• UDI-Device Identifier: 03700296900844
• UDI-Public: 03700296900844
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061445
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/06/2018

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?: No
• Device Operator: Physician
• Device Expiration Date: 12/19/2019
• Device Model Number: SURGIMESH WN
• Device Catalogue Number: TEALFIL-8
• Device Lot Number: F11004A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/07/2018
• Initial Date FDA Received: 03/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention