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

Model Number 5194001400

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Micturition Urgency (1871); Incontinence (1928); Pain (1994); Urinary Retention (2119)

Event Date 11/07/2016

Event Type  Injury  

Manufacturer Narrative

Device not returned.

Event Description

Patient's legal representative stated difficulty emptying bladder, small amount of leakage, right lower quadrant pain, urgency, difficulty voiding, and atypical lesion on the left hemitrigone of the bladder.

• 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: selanna martorana ; via fratelli meliga 1/c; chivasso, torino 10034 ; IT 10034 ; 9011919623
• MDR Report Key: 6215304
• MDR Text Key: 63612016
• Report Number: 9614846-2016-00295
• Device Sequence Number: 1
• Product Code: PAH
• UDI-Device Identifier: 28032919892120
• UDI-Public: 28032919892120
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 12/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 02/01/2014
• Device Model Number: 5194001400
• Device Lot Number: 0622
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Congenital Anomaly; Hospitalization; Required Intervention; Disability