MAUDE Adverse Event Report: HERNIAMESH SRL T-SLING; URINARY INCONTINENCE SLING

Model Number 5194001400

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

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

Event Date 12/20/2012

Event Type  Injury  

Manufacturer Narrative

Not returned.

Event Description

Plaintiff implanted with t-sling 5194001400 lot 0643 on (b)(6) 2012 alleges posterior colporrhaphy, rectocele repair and cystourethroscopy under general endotracheal anesthesia re-hospitalization and additional surgery of plaintiff occurred on (b)(6) 2012.

• Brand Name: T-SLING
• Type of Device: URINARY INCONTINENCE SLING
• Manufacturer (Section D): HERNIAMESH SRL; via fratelli meliga 1/c; chivasso, torino 10034 ; IT 10034
• Manufacturer (Section G): HERNIAMESH SRL; via fratelli meliga 1/c; chivasso, torino 10034 ; IT 10034
• Manufacturer Contact: selanna martorana ; via fratelli meliga 1/c; chivasso, torino 10034 ; IT 10034 ; 9011919623
• MDR Report Key: 5852871
• MDR Text Key: 51344006
• Report Number: 9614846-2016-00166
• Device Sequence Number: 1
• Product Code: PAH
• UDI-Device Identifier: 28032919892120
• UDI-Public: 28032919892120
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial
• Report Date: 08/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 5194001400
• Date Manufacturer Received: 08/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization