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

Model Number 5194001400

Device Problem Material Erosion (1214)

Patient Problem No Code Available (3191)

Event Date 12/15/2014

Event Type  Injury  

Manufacturer Narrative

Not returned.

Event Description

Plaintiff implanted with t-sling 5194001400 lot 0894 alleges vaginal wall mesh erosion re-hospitalization of plaintiff on (b)(6) 2014 - excision of vaginal wall mesh erosion with repair of vaginal wall under general anesthesia; erosion is 1 cm x 5 cm.

• 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: 5852829
• MDR Text Key: 51344320
• Report Number: 9614846-2016-00144
• Device Sequence Number: 1
• Product Code: PAH
• UDI-Device Identifier: 28032919892120
• UDI-Public: 28032919892120
• 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: 08/04/2016

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: 11/29/2017
• Device Model Number: 5194001400
• Device Lot Number: 0894
• Initial Date Manufacturer Received: 07/20/2016
• Initial Date FDA Received: 08/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization