MAUDE Adverse Event Report: HERNIAMESH SRL T-SLING

Model Number TS10X

Device Problems Leak/Splash (1354); Unintended Movement (3026)

Patient Problems Erosion (1750); Calcium Deposits/Calcification (1758); Incontinence (1928); Pain (1994); Urinary Tract Infection (2120); No Code Available (3191)

Event Date 03/30/2015

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 area pain, mesh erosion, recurrent vaginal and urinary infections, continued incontinence, leakage, bladder stones, bladder damage, abnormal vaginal odor, and the need for an additional surgery.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: 5207285
• MDR Text Key: 30593932
• Report Number: 9614846-2015-00104
• 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

• Date FDA Received: 11/06/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 05/05/2011
• Device Model Number: TS10X
• Device Lot Number: 0388
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2006
• 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