MAUDE Adverse Event Report: BOSTON SCIENTIFIC UROGYNEOLOGIC SURGICAL MESH IMPLANT

Device Problem Positioning Problem (3009)

Patient Problem No Code Available (3191)

Event Date 12/31/2010

Event Type  Injury  

Event Description

It was a gradual process, slowly my bladder was stretching; feels like it is coming down again.Not sure if the pig skin is moving or sliding inside of me.

• Brand Name: UROGYNEOLOGIC SURGICAL MESH IMPLANT
• Type of Device: UROGYNEOLOGIC SURGICAL MESH IMPLANT
• Manufacturer (Section D): BOSTON SCIENTIFIC
• MDR Report Key: 5662255
• MDR Text Key: 45486974
• Report Number: MW5062345
• Device Sequence Number: 1
• Product Code: PAJ
• 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: 05/14/2016

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: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/14/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 73 YR
• Patient Weight: 84