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

Catalog Number 5194001400

Device Problem Insufficient Information (3190)

Patient Problems Incontinence (1928); Therapeutic Response, Decreased (2271); Fibrosis (3167)

Event Date 02/27/2013

Event Type  Injury  

Event Description

The patient was implanted with herniamesh t-sling.Later the patient experienced recurrent stress urinary incontinence after a bout of heavy coughing with a cold and fibrosis.A placement of a competitor's sling with cystoscopy 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: 4058272
• MDR Text Key: 4859649
• Report Number: 9614846-2014-00012
• 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: 06/09/2014

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: Other
• Device Catalogue Number: 5194001400
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/04/2014
• Initial Date FDA Received: 08/06/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 56 YR