MAUDE Adverse Event Report: HERNIAMESH SRL T-SLING; URINARY INCONTINENCE SLING

Model Number 5194001400

Device Problem Insufficient Information (3190)

Patient Problems Incontinence (1928); Irritation (1941); Pain (1994)

Event Date 09/21/2016

Event Type  Injury  

Manufacturer Narrative

Device not returned.

Event Description

Plaintiff after implantation of t-sling 5194001400, lot 0687 on (b)(6) 2012 alleges pelvic pain and right groin pain, possible irritation of obturator nerve, over active bladder and sui.After different surgery, the mesh was remove on (b)(6) 2015.

• Brand Name: T-SLING
• Type of Device: URINARY INCONTINENCE SLING
• Manufacturer (Section D): HERNIAMESH SRL; via fratelli meliga 1/c; chivasso, torino 10034 ; IT 10034
• Manufacturer (Section G): HERNIAMESH SRL; via fratelli meliga 1/c; chivasso, torino 10034 ; IT 10034
• Manufacturer Contact: selanna martorana ; via fratelli meliga 1/c; chivasso, torino 10034 ; IT 10034 ; 9011919623
• MDR Report Key: 5798514
• MDR Text Key: 49678066
• Report Number: 9614846-2016-00142
• Device Sequence Number: 1
• Product Code: PAH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial
• Report Date: 07/15/2016

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 Expiration Date: 10/09/2014
• Device Model Number: 5194001400
• Device Lot Number: 0687
• Initial Date Manufacturer Received: 07/06/2016
• Initial Date FDA Received: 07/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2009
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization