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

Model Number 5194001400

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Unspecified Infection (1930); Urinary Retention (2119); Urinary Tract Infection (2120); Obstruction/Occlusion (2422)

Event Date 11/22/2011

Event Type  Injury  

Manufacturer Narrative

Not returned.

Event Description

Plaintiff implanted with t-sling (b)(4) lot 0691 alleges urinary obstruction, uti, hesitancy, nocturia, urinary retention symptoms are reportable to mesh exposure in the vagina, an early complication and the possible causes are: inadequate vaginal suture, superficial applications surgical technique, vaginal atrophy / lack of vascularization, infection, previous vaginal surgery.Re-hospitalization of plaintiff on (b)(6) 2011- incision of pubovaginal sling, cystoscopy and blunt urethrostomy under general anesthesia.

• 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: 5852830
• MDR Text Key: 51344222
• Report Number: 9614846-2016-00143
• 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 Expiration Date: 10/13/2014
• Device Model Number: 5194001400
• Device Lot Number: 0691
• Date Manufacturer Received: 07/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2009
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization