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 08/16/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The surgeon implanted a surgimesh wn tealfil-8, plug portion only, to repair the patient's inguinal hernia on (b)(6) 2015.The wn tealfil-8 was taken from a sterile package in the operating field.Antibiotics were initiated for the patient on (b)(6) 2016 due to a developing infection.The surgeon partially removed the wn tealfil-8 plug on (b)(6) 2016.The rest of the wn tealfil-8 plug remained in the patient.This case is one (1) of five (5) removals for infection out of approximately 530 open inguinal repairs (<1% infection rate) 08162016 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: 7325765
• MDR Text Key: 101959180
• Report Number: 3006617478-2018-00004
• 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: 05/23/2019
• Device Model Number: SURGIMESH WN
• Device Catalogue Number: TEALFIL-8
• Device Lot Number: F09720A
• 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: 05/23/2014
• 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