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

Catalog Number 5194001400

Device Problems Device Contamination with Chemical or Other Material (2944); Material Deformation (2976)

Patient Problems Pain (1994); Burning Sensation (2146)

Event Date 09/16/2013

Event Type  No Answer Provided  

Event Description

The patient was implanted with herniamesh t-sling.Later, the patient experienced vaginal burning at night, pelvic pain that is localized to the area of the tot tape, dyspareunia and has over contraction of the sling, tenderness, banded sling, some levator tenderness on the left, severe left vaginal wall pain and tight band across left vaginal wall from sling.Estradiol was prescribed [date not provided].A removal of mid-urethral sling (fragment of pink-tan mucosa measures 1.1 x 0.8 x 0.6 mm; two pieces of red-tan foreign material interpenetrated by tissue; the larger measures 2.5 x 1.2 x 0.3 cm and the smaller measures 1.5 x 1 x 0.2 cm), urethrolysis and 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 1034 ; IT 1034
• Manufacturer Contact: robert lamberti ; v. f.lli meliga 1/c; chivasso 1034 ; IT 1034
• MDR Report Key: 4236992
• MDR Text Key: 5076881
• Report Number: 9614846-2014-00023
• 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: 09/04/2014
• Initial Date FDA Received: 11/03/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 48 YR