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

Model Number SURGIMESH WN

Device Problem Microbial Contamination of Device (2303)

Patient Problem Seroma (2069)

Event Date 12/12/2017

Event Type  Injury  

Event Description

An open incisional hernia repair was performed on the anterior surface of the patients abdominal on (b)(6) 2017. The surgimesh wn was implanted on the patients midline located on top of fascia. The surgimesh wn was a single use sterile device removed from its sterile packaging in the operating field. A drain was inserted at the end of the procedure and removed on (b)(6) 2017. A seroma was noted to have formed on (b)(6) 2017. The surgeon involved chose to not administer antibiotics and the surgimesh wn was removed on (b)(6) 2017.

• 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: 7205099
• MDR Text Key: 97716706
• Report Number: 3006617478-2018-00001
• Device Sequence Number: 1
• Product Code: FTL
• 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

• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 01/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 06/11/2019
• Device Model Number: SURGIMESH WN
• Device Catalogue Number: T1115-8
• Device Lot Number: F1219A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 01/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/30/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 01/19/2018 Patient Sequence Number: 1