MalfunctionPLL
ORISE GEL
Received Sep 22, 2022 · Event occurred Sep 9, 2022
Report 15462261 · MDR key 15462261
Device
Generic name
Submucosal Injection Agent
Manufacturer
Boston Scientific CorporationModel number
M00519200Lot number
28942502
Product problems
- Break
Patient
Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
GLASS SYRINGE BROKE OFF HUB CONNECTOR (AND GLASS PIECE STAYED IN INJECTOR THAT WE WERE USING) WHILE INJECTING AND SPRAYED MD IN FACE AND EYES.