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

Catalog Number 5194001400

Device Problem Unexpected Therapeutic Results (1631)

Patient Problems Incontinence (1928); Unspecified Infection (1930); Pain (1994); Prolapse (2475); Dysuria (2684)

Event Date 11/07/2012

Event Type  No Answer Provided  

Event Description

The patient was implanted with herniamesh t-sling.Later the patient experienced infection, pain, incontinence, dysuria, pelvic organ prolapse and atrophy.Between (b)(6) 2012 premarin, rapaflo, garamycin, vesicare and myrbetriq were prescribed and a cystoscopy and catheterization were conducted.Urethrolysis was performed on (b)(6) 2012.

• Brand Name: T-SLING
• Type of Device: NONE
• Manufacturer (Section D): HERNIAMESH S.R.L.; via f.lli meliga 1/c; chivasso ; IT
• Manufacturer Contact: roberta lamberti ; via f.lli meliga 1/c; chivasso ; IT
• MDR Report Key: 4237010
• MDR Text Key: 18869008
• Report Number: 9614846-2014-00025
• 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 Catalogue Number: 5194001400
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/05/2014
• Initial Date FDA Received: 11/03/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 66 YR