MAUDE Adverse Event Report: UNKNOWN BLADDER SLING; Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator

Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Other
Event or Problem Description
The patient mentioned unrelated medical history.This included that patient said has had a bladder sling placed in 2007 and that worked for maybe 2-3 years however said that it didn't work anymore.This report reflects information received by fda in form of a notification per 803.22 (b)(2).

• Brand Name: BLADDER SLING
• Common Device Name: Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 50258810
• Report Number: MW6001048
• Device Sequence Number: 13356857
• Product Code: OTN
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Type of Report: Initial
• Report Date (Section B): 08/10/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/14/2026
• Patient Sequence Number: 1
• Patient Sex: Unknown