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

Model Number SURGIMESH XB

Device Problem Device Issue (2379)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 05/17/2016

Event Type  Injury  

Manufacturer Narrative

The physician specified in the declaration the following : "the situation was not related to the performance of the xb e-2226 but rather the patients health status which includes vascular disease".

Event Description

The distributor reported that : "on (b)(6) 2015 the patient received a surgimesh xb e-2226 to repair a ventral hernia.On (b)(6) 2015 the patient was brought back for an exploratory surgery to debride some tissue in the area of the hernia repair.On (b)(6) 2016 the patient was again brought back as the xb e-2226 was "bunched up" in an area.The xb e-2226 was removed and in the area where it had been the abdominal wall was solidly healed with no more hernia defect showing.The patient was closed and healed uneventfully.The surgeon stated that the situation was not related to the performance of the xb e-2226 but rather the patients health status which includes vascular disease.".

• Brand Name: SURGIMESH XB
• 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 ; 77531659
• MDR Report Key: 5747549
• MDR Text Key: 48092801
• Report Number: 3006617478-2016-00006
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/11/2016,06/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 09/26/2019
• Device Model Number: SURGIMESH XB
• Device Catalogue Number: XB TINTRA E2226
• Device Lot Number: 10267A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/11/2016
• Date Report to Manufacturer: 04/25/2016
• Date Manufacturer Received: 06/09/2016
• 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 Sequence Number: 1
• Patient Outcome(s): Required Intervention