MAUDE Adverse Event Report: HERNIAMESH SRL T-SLING; No Match

Model Number 5194001400

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Urinary Retention (2119); Urinary Tract Infection (2120); Genital Bleeding (4507)

Event Date 01/17/2022

Event Type  Injury  

Event Description

On (b)(6) 2015 and/or on (b)(6) 2015, unknown cystocele repair, unknown vaginal/rectal surgery and unknown tot mesh.On (b)(6) 2015 - on (b)(6) 2015, vaginal bleeding.Urge incontinence, urinary urgency on (b)(6) 2015, urinary frequency, urgency, incomplete bladder emptying, urinary incontinence.On (b)(6) 2016, urge incontinence, gross hematuria, claimants has 15 episodes of urge incontinence per day.Wears 3-4 pads daily.Urinates every 30 minutes during the day.Gets up 4 times at night.In-office cystoscopy shows mild urethral hypermobility and mild bladder trabeculation.On (b)(6) 2016, urge incontinence, urinary urgency.On (b)(6) 2022, documented severe voiding dysfunction, grade 3 rectocele.On (b)(6) 2022, removal of unknown tot mesh, posterior colporrhaphy.Intraoperative findings: the sling was noted to be extremely tight, deep to the periurethral fascia.Sling was dissected as it inserted into the obturator internus muscle bilaterally.Adverse events: vaginal bleeding, voiding dysfunction bladder storage issues.

• Brand Name: T-SLING
• Type of Device: No Match
• 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: federica bonini ; via fratelli meliga 1/c; chivasso, torino 10034 ; IT 10034
• MDR Report Key: 16384589
• MDR Text Key: 309642176
• Report Number: 9614846-2023-00002
• Device Sequence Number: 1
• Product Code: PAH
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 02/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2018
• Device Model Number: 5194001400
• Device Lot Number: 0920
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 67 YR
• Patient Sex: Female