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

Model Number 519400140C

Device Problem Material Erosion (1214)

Patient Problem Incontinence (1928)

Event Date 06/01/2012

Event Type  Injury  

Event Description

The pt was implanted with hernia mesh t-sling.Later, the pt experienced dyspareunia, 1 mm mesh erosion and return of incontinence.Under general anesthesia, a suburethral sling revision and cystourethroscopy were performed.

• Brand Name: T-SLING
• Type of Device: NONE
• Manufacturer (Section D): HERNIAMESH S.R.L.; 10034 chivasso (to); via fratelli; meliga 1/c ; IT
• Manufacturer Contact: lamberta roberta ; 10034 chivasso (to); via fratelli; meliga 1/c ; IT
• MDR Report Key: 3683194
• MDR Text Key: 4258338
• Report Number: 9614846-2014-00003
• 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: 02/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2014
• Device Model Number: 519400140C
• Device Lot Number: 2067346
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/21/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2009
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 51 YR