inforMED
MalfunctionPLL

ORISE¿ GEL

Received Apr 7, 2022 · Event occurred Mar 21, 2022

Report 14041869 · MDR key 14041869

Device

Generic name

Submucosal Injection Agent

Model number

M00519200

Lot number

28495209

Product problems

  • Break

Patient

27740 DA · Female

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

SLIP TIP OF ORISE 10 SYRINGE BROKE OFF INSIDE OF CONNECTOR PORT OF INJECTION NEEDLE.