MAUDE Adverse Event Report: BOSTON SCIENTIFIC SOLYX MESH

Lot Number 20883194

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 12/18/2017

Event Type  Injury  

Event Description

Solyx mesh implanted (b)(6) 2017 expelled by patient on (b)(6) 2017.

• Brand Name: SOLYX MESH
• Type of Device: SOLYX MESH
• Manufacturer (Section D): BOSTON SCIENTIFIC; gouverneur NY 13642
• MDR Report Key: 7142188
• MDR Text Key: 95735647
• Report Number: MW5074190
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 20883194
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR