MAUDE Adverse Event Report: BOSTON SCIENTIFIC SOLYX SLING; MESH

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Discomfort (2330); Prolapse (2475)

Event Date 10/26/2010

Event Type  Injury  

Event Description

Had bladder prolapse and had trans vaginal mesh sling implant by solyx.Has caused pelvic and vaginal pain, pain with intercourse.Is uncomfortable to stand or sit.Feels like a hot poker inside vagina at times like barb wire.It feels like something is protruding or still falling out.

• Brand Name: SOLYX SLING
• Type of Device: MESH
• Manufacturer (Section D): BOSTON SCIENTIFIC
• MDR Report Key: 3888999
• MDR Text Key: 4674392
• Report Number: MW5036732
• Device Sequence Number: 1
• Product Code: PAH
• 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: 06/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/17/2014
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Weight: 73