MalfunctionPLL
SUBMUCOSAL INJECTION AGENT
Received Dec 23, 2022
Report MW5114007 · MDR key 16051329
Device
Generic name
Orise Gel (submucosal Lifting Agent)
Manufacturer
Boston Scientific CorporationModel number
M00519200Catalog number
M00519200
Lot number
2931348
Product problems
- Nonstandard Device
Patient
Unknown
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
RECEIVED A RECALL NOTICE FOR BOSTON SCIENTIFIC'S ORISE GEL GTIN: (B)(4), REF: (B)(4). LOT: 29313438.