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

Catalog Number 5194001400

Device Problem Unexpected Therapeutic Results (1631)

Patient Problems Erosion (1750); Incontinence (1928); No Code Available (3191)

Event Date 01/26/2014

Event Type  No Answer Provided  

Event Description

The pt was implanted with hernia mesh t-sling.Later the pt experienced superficial centered tape erosion, dyspareunia, tape exposure right in the midline underneath the urethra, stress urinary incontinence and leakage.Tape was trimmed in office and e2 cream prescribed on (b)(6) 2011.A tape trim was attempted in office but was too uncomfortable on (b)(6) 2012.An excision of exposed vaginal tape was performed [in the hospital].Between (b)(6) 2012 and (b)(6) 2012 e2 cream, xylocaine ointment and toviaz were prescribed.

• Brand Name: T-SLING
• Type of Device: NONE
• Manufacturer (Section D): HERNIAMESH S.R.L.; v f.lli meliga 1/c; chivasso 1034 ; IT 1034
• Manufacturer Contact: roberta lamberti ; v f.lli meliga 1/c; chivasso 1034 ; IT 1034
• MDR Report Key: 4237011
• MDR Text Key: 5060598
• Report Number: 9614846-2014-00024
• 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: 09/17/2014

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 Expiration Date: 09/30/2014
• Device Catalogue Number: 5194001400
• Device Lot Number: WO2067346
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/04/2014
• Initial Date FDA Received: 11/03/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 58 YR