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

Model Number SURGIMESH XB

Device Problem Device Slipped (1584)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 12/29/2015

Event Type  Injury  

Manufacturer Narrative

This manufacturer report #3006617478-2016-00004 has been prepared further to reception of the importer report (b)(4).

Event Description

The distributer reported that : patient had an recurrent 3-defect ventral hernia repaired with a xb ok-1522 on (b)(6) 2013 that was the result of two prior c-sections.The surgeon agreed to repair the hernia as the patient stated that they planned no more pregnancies.The patient subsequently became pregnant and had another c-section.The patient experienced a recurrence in the area of the prior hernia repair with the xb ok-1522.On (b)(6) 2015 the patient returned to have the previously placed xb ok-1522 mesh explanted.The hernia defect was repaired using a new piece of xb ok-1522.The patient recovered uneventfully.

• 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: 5567134
• MDR Text Key: 42309813
• Report Number: 3006617478-2016-00004
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072974
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 02/28/2014
• Device Model Number: SURGIMESH XB
• Device Catalogue Number: TINTRAOK1522
• Device Lot Number: F07444A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2014
• 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