MAUDE Adverse Event Report: HERNIAMESH SRL T-SLING

Model Number 5194001400

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Discomfort (2330)

Event Date 12/16/2014

Event Type  Injury  

Event Description

Information received from (b)(4): patient has a past medical history of a synthetic mid urethral sling for stress incontinence.She postoperatively could feel the mesh during intercourse and had discomfort with this.There was a thin area over the mesh and the patient was trialed on premarin cream; however, this was unsuccessful.Given this, she presented today for the or to have removal of exposed mesh.Patient had dissection and removal of exposed vaginal mesh.Device usage problem: device malfunction - that is, the device did not do what it was supposed to do.

• Brand Name: T-SLING
• Type of Device: T-SLING
• Manufacturer (Section D): HERNIAMESH SRL; via fratelli meliga 1/c; chivasso, torino 10070 ; IT 10070
• Manufacturer (Section G): HERNIAMESH SRL; via fratelli meliga 1/c; chivasso, torino 10070 ; IT 10070
• Manufacturer Contact: selanna martorana ; via fratelli meliga 1/c; chivasso, torino 10070 ; IT 10070 ; 9011919623
• MDR Report Key: 5485470
• MDR Text Key: 39850914
• Report Number: 9614846-2016-00136
• Device Sequence Number: 1
• Product Code: PAH
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 03/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 5194001400
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/16/2016
• Initial Date FDA Received: 03/08/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other