MAUDE Adverse Event Report: HERNIAMESH SRL T-SLING

Device Problem Material Erosion (1214)

Patient Problems Abdominal Pain (1685); Incontinence (1928); Pain (1994); Injury (2348); No Code Available (3191)

Event Date 06/24/2013

Event Type  Injury  

Event Description

The patient was implanted with a herniamesh t-sling lot not available on (b)(6) 2004.Many years later legal complaint states that the patient suffered serious bodily injuries, including, but not limited to, extreme pain, vaginal erosion, dyspareunia, abdominal and pelvic pain, recurrence of urinary incontinence, additional surgery and/or other injuries.As well as significant mental and physical pain and suffering.No further information has been provided.

• Brand Name: T-SLING
• Type of Device: 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: 5466804
• MDR Text Key: 39255312
• Report Number: 9614846-2016-00077
• 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: 02/12/2016

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/01/2013
• Initial Date FDA Received: 02/29/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other