MAUDE Adverse Event Report: HERNIAMESH S.R.L. T-SLING; NONE

Catalog Number 5194001400

Device Problems Loose or Intermittent Connection (1371); Material Separation (1562); Torn Material (3024)

Patient Problems Erosion (1750); Purulent Discharge (1812); Hemorrhage/Bleeding (1888); Incontinence (1928); Unspecified Infection (1930); Pain (1994); Dysuria (2684)

Event Date 04/30/2012

Event Type  Injury  

Event Description

The patient was implanted with herniamesh t-sling on (b)(6) 2011.Later the patient experienced exposure on the left side, size not noted, infection, pelvic pain, recurrent stress urinary incontinence, bleeding, difficulty emptying bladder, erosion and dyspareunia.A post operative visit on (b)(6) 2011 showed purulent drainage from incision; incision had separated and mesh could be palpated; antibiotics were prescribed.On (b)(6) 2011 the mesh was exposed; estrace cream and patch were prescribed.On (b)(6) 2011 mesh exposed and reported difficulty emptying bladder; estrace cream and patch for treatment.On (b)(6) 2012 reports recurrent incontinence, pelvic pain, exposure present; antibiotics prescribed.An excision of mesh on (b)(6) 2012; exposed mesh was described as very loose and torn.

• Brand Name: T-SLING
• Type of Device: NONE
• Manufacturer (Section D): HERNIAMESH S.R.L.; via fratelli meliga 1/c; chivasso 1003 4
• Manufacturer Contact: selanna martorana ; via fratelli meliga 1/c; chivasso, torino 10034 ; IT 10034
• MDR Report Key: 4701433
• MDR Text Key: 5649143
• Report Number: 9614846-2015-00048
• 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: Unknown
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 5194001400
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/26/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 39 YR