MAUDE Adverse Event Report: HERNIAMESH S.R.L. T-SLING; NONE

Catalog Number 5194001400

Device Problem Material Erosion (1214)

Patient Problems Incontinence (1928); Pain (1994)

Event Date 11/26/2013

Event Type  Injury  

Event Description

The patient was implanted with a competitor's product on (b)(6) 2010 and herniamesh t-sling on (b)(6) 2011.Later the patient experienced recurrent incontinence, dyspareunia, erosion on the left side, exact size not noted, and erosion 2mm on the right side.An excision of eroded mesh was performed on (b)(6) 2010.During the t-sling placement on (b)(6) 2011, 2 areas of flesh were cauterized in the vagina vault.An excision of the sling, unclear if it was the competitor's product or the t-sling, was performed on (b)(6) 2012.An excision of mesh, unclear if it was the competitor's product or the t-sling, was performed on (b)(6) 2013.

• Brand Name: T-SLING
• Type of Device: NONE
• Manufacturer (Section D): HERNIAMESH S.R.L.; via fratelli meliga 1/c; chivasso 1003 4
• Manufacturer Contact: selanna martorana ; via fratelli meliga 1/c; chivasso 10034
• MDR Report Key: 4701431
• MDR Text Key: 15392183
• Report Number: 9614846-2015-00046
• 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: Unknown
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 09/30/2014
• Device Catalogue Number: 5194001400
• Device Lot Number: 2067346
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/26/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2009
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 69 YR