MAUDE Adverse Event Report: ASPIDE MEDICAL SURGIMESH XB ; TINTRA OK-1522

Model Number TINTRA OK-1522

Device Problem Device Slipped (1584)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 12/29/2015

Event Type  Injury  

Event Description

Patient had a 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: TINTRA OK-1522
• Manufacturer (Section D): ASPIDE MEDICAL ; 246 allee lavoisier; latalaudiere 42350 FR; FR 42350 FR
• Manufacturer (Section G): BG MEDICAL LLC; 20925 pheasant trail; suite 100; deer park IL 60010
• Manufacturer Contact: 20925 pheasant trail; suite 100; deer park, IL 60010
• MDR Report Key: 5427431
• MDR Text Key: 37959635
• Report Number: 3005841068-2016-00001
• Device Sequence Number: 1
• Product Code: FTL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/03/2016,01/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2014
• Device Model Number: TINTRA OK-1522
• Device Catalogue Number: TINTRA OK-1522
• Device Lot Number: F07444A
• 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: 02/03/2016
• Distributor Facility Aware Date: 01/04/2016
• Device Age: 28 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/03/2016
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 21 YR