MAUDE Adverse Event Report: HERNIAMESH S.R.L. T-SLING

Catalog Number 5194001400

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erosion (1750); Hemorrhage/Bleeding (1888); Incontinence (1928); Pain (1994); Abnormal Vaginal Discharge (2123); Therapeutic Response, Decreased (2271)

Event Date 06/13/2013

Event Type  Other  

Event Description

The patient was implanted with herniamesh t-sling.Later the patient experienced stress urinary incontinence, pelvic pain, dyspareunia, bloody discharge, pain with palpating of mid suburethra and possible mesh erosion.An exam was performed on (b)(6) 2013 with no exposure of mesh noted.An exploration, urethrolysis and possible retaping considering the incontinence issues, depending on the status of the tissue is discussed on (b)(6) 2013.A urethra lysis post cyst noted.

• Brand Name: T-SLING
• Type of Device: NA
• Manufacturer (Section D): HERNIAMESH S.R.L.; via fratelli meliga 1/c; chivasso, torino ; IT
• Manufacturer Contact: roberta lamberti ; via fratelli meliga 1/c; chivasso, torino ; IT
• MDR Report Key: 4236987
• MDR Text Key: 5076358
• Report Number: 9614846-2014-00029
• Device Sequence Number: 1
• Product Code: PAH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020652
• 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: 09/30/2014

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: Other
• Device Expiration Date: 11/30/2016
• Device Catalogue Number: 5194001400
• Device Lot Number: WO3062982
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/29/2014
• Initial Date FDA Received: 11/03/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR