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

Model Number M00519200

Device Problem Nonstandard Device (1420)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Received a recall notice for boston scientific's orise gel gtin: (b)(4), ref: (b)(4).Lot: 29313438.

• Brand Name: SUBMUCOSAL INJECTION AGENT
• Type of Device: ORISE GEL (SUBMUCOSAL LIFTING AGENT)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 16051329
• MDR Text Key: 306346140
• Report Number: MW5114007
• Device Sequence Number: 1
• Product Code: PLL
• UDI-Device Identifier: 08714729974567
• UDI-Public: (01)08714729974567
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 12/19/2022

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
• Device Expiration Date: 04/28/2024
• Device Model Number: M00519200
• Device Catalogue Number: M00519200
• Device Lot Number: 2931348
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/23/2022
• Patient Sequence Number: 1