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

Model Number 5194001400

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Erosion (1750); Incontinence (1928); Muscle Spasm(s) (1966); Perforation (2001); Urinary Retention (2119); Urinary Tract Infection (2120); Urinary Frequency (2275); Fungal Infection (2419); Hematuria (2558); Dysuria (2684)

Event Date 04/09/2013

Event Type  Injury  

Manufacturer Narrative

Not returned.

Event Description

Plaintiff after implantation of t-sling 5194001400 lot 0650 on (b)(6) 2011 alleges urinary retention, chronic uti, dysuria, nocturia, frequency, voiding dysfunction, erosion, hematuria, bladder spasms, fungal vaginitis, mixed incontinence, loss of consortium, dyspareunia, organ perforation.Re-hospitalization for mesh revision/ removal occurred on (b)(6) 2012 and (b)(6) 2013.

• 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: 5852845
• MDR Text Key: 51343773
• Report Number: 9614846-2016-00150
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 07/01/2014
• Device Model Number: 5194001400
• Device Lot Number: 0650
• Initial Date Manufacturer Received: 07/21/2016
• Initial Date FDA Received: 08/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/24/2009
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization