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

Model Number	5194001400
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Incontinence (1928); Pain (1994); Urinary Tract Infection (2120); Patient Problem/Medical Problem (2688); No Code Available (3191)
Date of Event	10/31/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient's legal representative stated severe pain with daily activities and intercourse, chronic urinary tract infections, as well as vaginal bleeding, reoccurring stress "incontinece", and urge incontinence.

• 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, italy ; IT
• MDR Report Key: 8073210
• Report Number: 9614846-2018-00009
• Device Sequence Number: 1732368
• 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: 2013
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/15/2018

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: 0670
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/26/2018
• Initial Report FDA Received Date: 11/15/2018
• 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: Hospitalization