MAUDE Adverse Event Report: HERNIAMESH SRL T-SLING PP; No Match

Catalog Number	51940
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Intermenstrual Bleeding (2665); Dyspareunia (4505); Urinary Incontinence (4572); Pelvic Pain (4865)
Date of Event	09/30/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient's legal representative stated the patient suffered complications including but not limited to, pelvic pain, protrusion, extrusion, erosion, urinary issues, recurrence, bleeding, dyspareunia, heavy discharge, vaginal scarring, permanent disfigurement, and difficulty with daily activities, which ultimately required surgical intervention and removal of mesh: on (b)(6) 2023 light pink colored discharge after intercourse, palpable rough textured area in anterior vagina (~3 mm) in diameter ~3 cm from vaginal opening, however unable to visualize this area with speculum exam, (+) bacterial vaginosis.On (b)(6) 2023 consultation - palpable anterior vaginal wall rough/irregular ridge just inside introitus, area not visible, area is most likely mesh from bladder repair, no erosion through vaginal mucosa.On (b)(6) 2023 pink colored discharge after intercourse, (+) bacterial vaginosis, (+) vaginal candidiasis.On (b)(6) 2023 urinary frequency/dysuria, bladder pressure, uti with hematuria (+) e coli.On (b)(6) 2024 uti.On (b)(6) 2024 vaginal itching and discharge, intermittent vaginal spotting, erosion of mesh from prior bladder repair that is eroded through vaginal wall, (+) vaginal candidiasis.On (b)(6) 2024 vaginal mesh erosion, pelvic/perineal pain vaginal mesh (t-sling) removal.

• Brand Name: T-SLING PP
• Common Device Name: No Match
• Manufacturer (Section D): HERNIAMESH SRL; via fratelli meliga 1/c; chivasso, torino 10034 ; IT 10034
• Manufacturer (Section G): HENRIAMESH SRL; via fratelli meliga 1/c; chivasso, torino 10034 ; IT 10034
• Manufacturer Contact: chiara trivero ; via fratelli meliga 1/c; chivasso, torino 10034 ; IT 10034
• MDR Report Key: 22520616
• Report Number: 9614846-2025-00001
• Device Sequence Number: 8078913
• Product Code: PAH
• UDI-Device Identifier: 18032919892123
• UDI-Public: 18032919892123
• 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 Explanted Year: 2024
• 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): 07/16/2025

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 Catalogue Number: 51940
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2025
• Initial Report FDA Received Date: 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: Hospitalization
• Patient Sex: Female