MAUDE Adverse Event Report: BOSTON SCIENTIFIC BLADDER SLING

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Incontinence (1928); Pain (1994); Tissue Damage (2104)

Event Type  Other  

Event Description

The sling was implanted in 2008 for bladder incontinence, and was removed in 2009 because it caused the bladder to shrink.Pt's bladder could only hold up to 2 ounces of fluid.Pt was having a lot of pain.Pt had 2 other surgical procedures in 2010, still for incontinence.On (b)(6) 2013, doctor injected botox into the bladder to make it swell and be able to hold more fluid.This will be done every 6 months.Pt is allowed to drink only water and milk.No drinks that contain caffeine.

• Brand Name: BLADDER SLING
• Type of Device: SLING
• Manufacturer (Section D): BOSTON SCIENTIFIC
• MDR Report Key: 3586667
• MDR Text Key: 17842465
• Report Number: MW5033899
• Device Sequence Number: 1
• Product Code: OTN
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 01/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/17/2014
• Patient Sequence Number: 1