MAUDE Adverse Event Report: HERNIAMESH SRL T-SLING

Model Number TS10

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Incontinence (1928); Unspecified Infection (1930); Pain (1994); Urinary Retention (2119); Abnormal Vaginal Discharge (2123); No Code Available (3191)

Event Date 03/24/2015

Event Type  Injury  

Event Description

Event was reported to herniamesh by the distributor who receive a legal complaint by the patient attorney.The patient has suffered chronic pelvic and vaginal area pain, pain during intercourse infections, worsened urinary incontinence, retention, leakage, urinary and vaginal infections, abnormal bowel movements, vaginal bleeding, sharp nerve pain on lower right side, abnormal vaginal discharge, and need for additional surgical procedures.No further information has been provided.

• Brand Name: T-SLING
• Type of Device: T-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: 5207297
• MDR Text Key: 30594239
• Report Number: 9614846-2015-00108
• 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: 05/11/2015

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: 01/26/2012
• Device Model Number: TS10
• Device Lot Number: 0473
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/15/2015
• Initial Date FDA Received: 11/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2007
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention