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

Model Number 5194001400

Device Problem Insufficient Information (3190)

Patient Problems Hemorrhage/Bleeding (1888); Incontinence (1928); Pain (1994); Urinary Tract Infection (2120); Patient Problem/Medical Problem (2688); No Code Available (3191)

Event Date 10/31/2016

Event Type  Injury  

Event 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
• Type of Device: DEVICE FOR STRESS URINARY INCONTINENCE
• Manufacturer (Section D): HERNIAMESH SRL; via fratelli meliga 1/c; chivasso 10034 torino, italy ; IT
• Manufacturer (Section G): COLOPLAST CORP; minneapolis mn 55411, us
• Manufacturer Contact: selanna martorana ; via f.lli meliga 1/c; chivasso (to), 10034 ; IT 10034
• MDR Report Key: 8073210
• MDR Text Key: 127218342
• Report Number: 9614846-2018-00009
• Device Sequence Number: 1
• Product Code: PAH
• UDI-Device Identifier: 28032919892120
• UDI-Public: 28032919892120
• Combination Product (y/n): N
• 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: 11/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 09/01/2014
• Device Model Number: 5194001400
• Device Lot Number: 0670
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization