MAUDE Adverse Event Report: ASPIDE MEDICAL SURGIMESH

Model Number SURGIMESH XB

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Distress (2329)

Event Date 12/29/2014

Event Type  Injury  

Event Description

Incident involved two (2) meshes.Also, see mdr 3005841068-2015-00001.Surgeon had a pt who was experiencing abdominal pain and appeared to have recurrent ventral and umbilical hernias.Upon exploration on (b)(6) 2014, the surgeon found an xb c-12 from the prior hernia repair incorporated but separated with multiple fatty adhesions between the mesh and abdominal wall.Also, from the prior hernia repair, an xb ck-7 near the umbilical area was found wrinkled and needed to be removed.The surgeon implanted two add'l pieces of xb mesh (xb(b)(4)) which resolved the hernias.The surgeon stated that perhaps he didn't allow for adequate margins around the previously placed meshes and that the pt's health status (diabetes/heart disease) negatively affected the healing.On (b)(6) 2015, the surgeon reported that the pt was doing well and had not complained of any further distress.

• Brand Name: SURGIMESH
• Type of Device: SURGIMESH
• Manufacturer (Section D): ASPIDE MEDICAL; 246 altec lavoistier; la talaudiere 4235 0; FR 42350
• Manufacturer Contact: 246 altec lavoisier; la talaudiere 42350 ; 77531659
• MDR Report Key: 4541772
• MDR Text Key: 17219984
• Report Number: 3005841068-2015-00002
• 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: Distributor
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/16/2015,02/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 12/14/2014
• Device Model Number: SURGIMESH XB
• Device Catalogue Number: TINTRA CK-7
• Device Lot Number: F08548A
• 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: 02/18/2015
• Distributor Facility Aware Date: 12/29/2014
• Event Location: Hospital
• Date Report to Manufacturer: 02/18/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/01/2013
• 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