MAUDE Adverse Event Report: HERNIAMESH SRL T-SLING

Model Number 5194001400

Device Problems Material Too Rigid or Stiff (1544); Extrusion (2934); Positioning Problem (3009)

Patient Problems Erosion (1750); Irritation (1941); Pain (1994)

Event Type  Injury  

Event Description

(b)(4).Physician relayed to rep that she has concerns about her mesh exposure rate from using t-sling as a retro-pubic sling over the past 2 years.She has documented 4 exposures of mesh which she says is "in the 8%" area of total mesh sling cases which she feels is too high.She has also noticed "too much palpability" of the t sling even without exposures.Although she is aware that the mesh density of t sling is actually a bit less than most other slings, she feels that the t sling mesh is "stiffer" and that may have something to do with these exposures.She says she rarely can get the entire width of the sling to be flat, where one of the two edges of the sling "ramp up" a bit.She hydrodissects and closes all incisions herself.She says none of these patients had any tissue complications which made her think a mesh sling wouldn't work well.In all the exposure cases, the patients were effectively treated with either in-clinic excision of exposed mesh, re-closure of wound, estrogen cream, etc and that all have been fine after secondary treatment.All four patients initially claimed palpability, dyspareunia, or irritation.

• Brand Name: T-SLING
• Type of Device: T-SLING
• Manufacturer (Section D): HERNIAMESH SRL; via fratelli meliga 1/c; chivasso, torino 10070 ; IT 10070
• Manufacturer (Section G): HERNIAMESH SRL; via fratelli meliga 1/c; chivasso, torino 10070 ; IT 10070
• Manufacturer Contact: selanna martorana ; via fratelli meliga 1/c; chivasso, torino 10070 ; IT 10070 ; 9011919623
• MDR Report Key: 5396223
• MDR Text Key: 36996824
• Report Number: 9614846-2016-00006
• Device Sequence Number: 1
• Product Code: PAH
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 01/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 5194001400
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/13/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other