MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLFLEX COLONIC; STENT, COLONIC, METALIC, EXPANDABLE

Model Number M00565050

Device Problem Insufficient Information (3190)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/28/2020

Event Type  No Answer Provided  

Event Description

No event description provided.Manufacturer response for device 1, stent wall flex colonic (per site reporter).

• Brand Name: WALLFLEX COLONIC
• Type of Device: STENT, COLONIC, METALIC, EXPANDABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 100 boston scientific way; marlborough MA 01752
• MDR Report Key: 10482143
• MDR Text Key: 205295989
• Report Number: 10482143
• Device Sequence Number: 1
• Product Code: MQR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2020
• Device Operator: No Information
• Device Model Number: M00565050
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/12/2020
• Date Report to Manufacturer: 09/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 23360 DA