MAUDE Adverse Event Report: HERNIAMESH SRL T-SLING

Model Number TS05

Device Problems Device Emits Odor (1425); Extrusion (2934)

Patient Problems Abdominal Pain (1685); Erosion (1750); Granuloma (1876); Incontinence (1928); Unspecified Infection (1930); Pain (1994); Tissue Damage (2104); Abnormal Vaginal Discharge (2123); Intermenstrual Bleeding (2665); Dysuria (2684); No Code Available (3191); Constipation (3274)

Event Date 03/23/2015

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 infections, vaginal pain, urinary problem, painful intercourse, bleeding, discharge, odor, incontinence, erosion of mesh, extrusion of mesh, granuloma formulation, pelvic pain, sores, constipation, and removal of mesh.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: 5207292
• MDR Text Key: 30593750
• Report Number: 9614846-2015-00107
• 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: 08/01/2012
• Device Model Number: TS05
• Device Lot Number: 0466
• 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: 08/01/2007
• 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