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

Model Number E1522

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 12/05/2015

Event Type  Injury  

Event Description

The importer reported that : "patient had surgery on (b)(6) 2015 for an incisional hernia repair.0 ethibond was used for the closing the fascia and securing the surgimesh.A jp drain was also placed.The patient experienced increasing drainage from the drain over the next 2 days.On (b)(6) 2015 the bloody drainage increased and the patient 's hematocrit dropped.The patient was taken back to surgery.The surgeon reported when the incision was reopened and a large clot was evacuated it was discovered that mesh had pulled away from the fascia and there was complete fascia dehiscence.The surgeon also reported that all but a handful of the 0 ethibond sutures on the left side had unraveled despite having 8 knots placed in them at the first.

• 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: 5401819
• MDR Text Key: 37233630
• Report Number: 3006617478-2016-00002
• 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: 01/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 08/11/2019
• Device Model Number: E1522
• Device Catalogue Number: E1522
• Device Lot Number: F10289A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/07/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/20/2013
• 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
• Patient Weight: 125