MAUDE Adverse Event Report: HERNIAMESH SRL T-SLING

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

Patient Problems Pain (1994); Patient Problem/Medical Problem (2688); No Code Available (3191)

Event Date 02/19/2015

Event Type  Injury  

Event Description

The patient was implanted with a herniamesh t-sling lot not available on (b)(6) 2006.Many years later legal complaint states that patient experienced significant mental and physical pain and suffering, has sustained permanent injury, will likely undergo further corrective surgery, has suffered financial or economic loss, including but not limited to, obligations for medical services and expenses, and has endured impaired physical relations.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: 5465860
• MDR Text Key: 39198346
• Report Number: 9614846-2016-00045
• 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: 02/11/2016

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: 10/15/2015
• 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