MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ORISE LIFTING AGENT; SUBMUCOSAL INJECTION AGENT

Device Problem Nonstandard Device (1420)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Product recalled, are patient records being updated as recommended by the company?.

• Brand Name: ORISE LIFTING AGENT
• Type of Device: SUBMUCOSAL INJECTION AGENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 16272690
• MDR Text Key: 308581756
• Report Number: MW5114576
• Device Sequence Number: 1
• Product Code: PLL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 01/27/2023

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?: Yes
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/30/2023
• Patient Sequence Number: 1