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

Catalog Number 5194001400

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Genital Bleeding (4507); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/22/2020

Event Type  Injury  

Event Description

Recurrent sui after previous sling removal secondary to pain.Adverse events: infection, pain, vaginal bleeding.Explant date: (b)(6) 2020.

• Brand Name: T-SLING
• Type of Device: URINARY INCONTINENCE SLING
• Manufacturer (Section D): HERNIAMESH SRL; via fratelli meliga 1/c; chivasso, torino 10034 ; IT 10034
• Manufacturer (Section G): HERNIAMESH SRL; via fratelli meliga 1/c; chivasso, torino 10034 ; IT 10034
• Manufacturer Contact: federica bonini ; via fratelli meliga 1/c; chivasso, torino 10034 ; IT 10034
• MDR Report Key: 16384590
• MDR Text Key: 309633543
• Report Number: 9614846-2023-00001
• 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: 02/06/2023

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: Health Professional
• Device Expiration Date: 05/31/2017
• Device Catalogue Number: 5194001400
• Device Lot Number: 0852
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/25/2023
• Initial Date FDA Received: 02/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/28/2012
• 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: 51 YR
• Patient Sex: Female