MAUDE Adverse Event Report: HERNIAMESH SRL T-SLING

Model Number CAL-TS10

Device Problem Extrusion (2934)

Patient Problems Abdominal Pain (1685); Erosion (1750); Hemorrhage/Bleeding (1888); Laceration(s) (1946); Pain (1994); Perforation (2001); Urinary Tract Infection (2120); Obstruction/Occlusion (2422)

Event Date 03/05/2015

Event Type  Injury  

Event Description

The patient was implanted with a herniamesh t-sling cal-ts10 lot.0473 on (b)(6) 2007 many years later the patient has suffered internal lacerations, several areas of the mesh perforated through the vaginal walls, extrusion and erosion of the mesh implant, vaginal bleeding, severe vaginal pain, chronic urinary tract infections, abdominal pain, rectal pain, bowel obstruction, and severe dyspareunia, and underwent revision and removal surgeries to decrease the likelihood of further bodily injuries and pain.No further information has been provided.

• Brand Name: T-SLING
• Type of Device: 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: 5465865
• MDR Text Key: 39200059
• Report Number: 9614846-2016-00048
• 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: 02/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 01/26/2012
• Device Model Number: CAL-TS10
• Device Lot Number: 0473
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/15/2015
• Date Device Manufactured: 02/06/2007
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other