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

Model Number	5194001400
Health Effect - Clinical Codes	Pain (1994); Injury (2348); No Code Available (3191)
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient's legal representative stated significant mental and physical pain and suffering, has sustained permanent injury, has undergone medical treatment and will likely undergo further medical treatment and procedures, loss of consortium.

• Brand Name: T-SLING
• Common Device Name: DEVICE FOR STRESS URINARY INCONTINENCE
• Manufacturer (Section D): HERNIAMESH SRL; via fratelli meliga 1/c; chivasso 10034 torino it, ; IT
• MDR Report Key: 7506651
• Report Number: 9614846-2018-00004
• Device Sequence Number: 11096181
• Product Code: PAH
• UDI-Device Identifier: 28032919892120
• UDI-Public: 28032919892120
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K020652
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/11/2018

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
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/10/2018
• Initial Report FDA Received Date: 05/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability