MAUDE Adverse Event Report: BOSTON SCIENTIFIC BLADDER SLING; MESH

Device Problem Insufficient Information (3190)

Patient Problems Fatigue (1849); Incontinence (1928); Pain (1994); Complaint, Ill-Defined (2331)

Event Type  Injury  

Event Description

I had a mesh (bladder sling) surgically placed sometime in 2008 and i have had problems since the surgery.Pelvic pain, pain during sex, continued incontinence, fatigue.Mesh cam from boston scientific.

• Brand Name: BLADDER SLING
• Type of Device: MESH
• Manufacturer (Section D): BOSTON SCIENTIFIC
• MDR Report Key: 5553724
• MDR Text Key: 42220435
• Report Number: MW5061501
• Device Sequence Number: 1
• Product Code: FTL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 36 YR
• Patient Weight: 83