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

Catalog Number 519400140C

Device Problem Device Slipped (1584)

Patient Problems Fistula (1862); Incontinence (1928); Pain (1994); Urinary Tract Infection (2120); Numbness (2415); Hematuria (2558); Dysuria (2684)

Event Date 03/27/2013

Event Type  Injury  

Event Description

The patient was implanted with a competitor's product and herniamesh t-sling.Later the patient experienced right hip pain, numbness over the left thigh with right groin pain, urine leakage with coughing, persistent urinary tract infections, dysuria, hematuria, colovesical fistula and the patient alleges the mesh is falling out.Mobic, tramadol and antibiotics were prescribed (date(s) not provided).A laparoscopic low anterior resection with diverting ileostomy for the colovesical fistula were performed.

• Brand Name: T-SLING
• Type of Device: NONE
• Manufacturer (Section D): HERNIAMESH S.R.L.; v. f.lli meliga 1/c; chivasso, torino ; IT
• MDR Report Key: 4058263
• MDR Text Key: 18070581
• Report Number: 9614846-2014-00017
• Device Sequence Number: 1
• Product Code: PAH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020652
• 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: 07/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 09/30/2014
• Device Catalogue Number: 519400140C
• Device Lot Number: WO2067346
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/30/2014
• Date Device Manufactured: 09/01/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 69 YR