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

Model Number	5194001400
Health Effect - Clinical Codes	Muscle Spasm(s) (1966); Urinary Tract Infection (2120)
Date of Event	07/26/2010
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient legal representative stated extrusion of vaginal mesh, recurrent uti's, muscle cramps.

• 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
• MDR Report Key: 7880520
• Report Number: 9614846-2018-00006
• Device Sequence Number: 13930295
• Product Code: PAH
• UDI-Device Identifier: 28032919892120
• UDI-Public: 28032919892120
• Combination Product (Y/N): N
• PMA/510(K) Number: K020652
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2010
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/17/2018

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 Expiration Date: 09/01/2014
• Device Model Number: 5194001400
• Device Lot Number: 0673
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/07/2018
• Initial Report FDA Received Date: 09/17/2018
• 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