MAUDE Adverse Event Report: HERNIAMESH T-SLING

Model Number CAL-TS10

Device Problem Extrusion (2934)

Patient Problems Erosion (1750); Incontinence (1928); Unspecified Infection (1930); Pain (1994); Therapeutic Response, Decreased (2271)

Event Date 09/12/2013

Event Type  Injury  

Event Description

Complaint was reported by the patient's attorney, as a result of product implantation, patient has experienced pain, erosion, infections, dyspareunia and incontinence.Symptoms are reportable to mesh exposure in the vagina, an early complication and the possible causes are: inadequate vaginal suture, superficial application, surgical technique, vaginal atrophy and lack of vascularization, infection, and previous vaginal surgery.

• Brand Name: T-SLING
• Type of Device: NA
• Manufacturer (Section D): HERNIAMESH ; via fratelli meliga 1/c; chivasso, (to) 10034 ; IT 10034
• Manufacturer Contact: selanna martorana ; via fratelli meliga 1/c; chivasso, (to) 10034 ; IT 10034
• MDR Report Key: 5045275
• MDR Text Key: 24817331
• Report Number: 9614846-2015-00093
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: unknown
• Reporter Occupation: Other
• Report Date: 08/25/2015

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: No Information
• Device Expiration Date: 01/01/2012
• Device Model Number: CAL-TS10
• Device Lot Number: 0465
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/28/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other