MAUDE Adverse Event Report: HERNIAMESH SRL T-SLING; URINARY INCONTINENCE SLING

Model Number	5194001400
Health Effect - Clinical Codes	Abdominal Pain (1685); Urinary Tract Infection (2120); Urinary Frequency / Polyuria (2275); Hematuria (2558); Lethargy (2560); Dysuria (2684); Dyspareunia (4505); Genital Bleeding (4507); Urinary Incontinence (4572)
Date of Event	09/14/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Legal representative stated severe and debilitating abdominal pain, vaginal bleeding, chronic urinary tract infections, urinary incontinence, dyspareunia, dysuria, hematuria, urinary frequency, lethargy, and mesh erosion some time after implant, erosion of mesh, serious bodily injury and harm, lethargy, undergone medical treatment, including multiple procedures to correct her injuries, and will likely undergo further medical treatment and procedures, exposure/extrusion/protrusion, infections, bladder problems.On (b)(6) 2020, revision surgery to remove sling.Partial excision/revision of eroded sling on (b)(6) 2020.Intraoperative finding: 1x1cm t-sling erosion in mid-vagina about 2cm from external urethral meatus.Excision size: 2cm.

• Brand Name: T-SLING
• Common Device Name: URINARY INCONTINENCE SLING
• Manufacturer (Section D): HERNIAMESH SRL; via fratelli meliga 1/c; chivasso, torino 10034 ; IT 10034
• MDR Report Key: 10934138
• Report Number: 9614846-2020-00001
• Device Sequence Number: 2758019
• Product Code: PAH
• UDI-Device Identifier: 28032919892120
• UDI-Public: 28032919892120
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K020652
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/02/2020

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
• Operator of Device: No Information
• Device Model Number: 5194001400
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/20/2020
• Initial Report FDA Received Date: 12/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention