MAUDE Adverse Event Report: BOSTON SCIENTIFIC TRANSVAGINAL MESH

Model Number ADVANTAGE FIT

Device Problem Difficult to Remove (1528)

Patient Problem No Code Available (3191)

Event Date 11/12/2015

Event Type  Injury  

Event Description

Had surgery to remove transvaginal mesh, out only pieces of it.

• Brand Name: TRANSVAGINAL MESH
• Type of Device: TRANSVAGINAL MESH
• Manufacturer (Section D): BOSTON SCIENTIFIC
• MDR Report Key: 5357945
• MDR Text Key: 35666464
• Report Number: MW5059156
• Device Sequence Number: 1
• Product Code: FTM
• 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: 01/06/2016

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: Health Professional
• Device Model Number: ADVANTAGE FIT
• Device Lot Number: M100000197
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/06/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 42 YR
• Patient Weight: 66