MAUDE Adverse Event Report: HERNIAMESH SRL T-SLING

Model Number CAL-TS10

Device Problems Material Erosion (1214); Extrusion (2934); Material Protrusion/Extrusion (2979)

Patient Problems Pain (1994); Scarring (2061); Dysuria (2684); No Code Available (3191)

Event Date 03/23/2015

Event Type  Injury  

Event Description

The patient was implanted with a herniamesh t-sling cal-ts10 lot 0266 on (b)(6) 2006.Many years later the patient has suffered vaginal pain, hardening of mesh, mesh protrusion, mesh erosion, painful intercourse, painful urination, dysuria, incomplete bladder emptying, pelvic pain, scarring, discharge, bleeding, extrusion of mesh, and corrective surgery.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: 5466673
• MDR Text Key: 39244554
• Report Number: 9614846-2016-00052
• 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: 02/04/2016

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: 09/19/2010
• Device Model Number: CAL-TS10
• Device Lot Number: 0266
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/15/2015
• Initial Date FDA Received: 02/29/2016
• Date Device Manufactured: 09/19/2005
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other