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

Catalog Number 519400140C

Device Problem Insufficient Information (3190)

Patient Problems Incontinence (1928); Urinary Retention (2119); Urinary Tract Infection (2120); Therapeutic Response, Decreased (2271); No Code Available (3191)

Event Date 03/05/2012

Event Type  Injury  

Event Description

The patient was implanted with herniamesh t-sling on (b)(6), 2011.Later the patient experienced urge incontinence, incomplete bladder emptying and urinary tract infection.A urethrolysis and pubovaginal sling graft about 4mm in length were performed on (b)(6), 2012.

• Brand Name: T-SLING
• Type of Device: NONE
• Manufacturer (Section D): HERNIAMESH S.R.L.; v. f.lli meliga 1/c; chivasso ; IT
• MDR Report Key: 4058276
• MDR Text Key: 4859651
• Report Number: 9614846-2014-00015
• 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: 07/03/2014

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: 519400140C
• Device Lot Number: WO2067346
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/27/2014
• Initial Date FDA Received: 08/06/2014
• 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: 66 YR