inforMED
MalfunctionKCP

REINER EAR SYRINGE

Received Dec 12, 2018 · Event occurred Oct 2, 2018

Report MW5082071 · MDR key 8160301

Device

Generic name

Syringe, Ent

Model number

MDS 4409710

Lot number

00081619

Product problems

  • Break

Patient

78 YR

  • Abrasion
  • Hemorrhage/Blood Loss/Bleeding
  • Pain
  • Abrasion
  • Hemorrhage/Blood Loss/Bleeding
  • Pain

Narrative

Description of Event or Problem

EAR IRRIGATION DONE FOR BILATERAL CERUMEN IMPACTION. DEVICE CAME APART DURING PROCEDURE, TIP WENT FORWARD - CAUSED ABRASION OF THE EAR CANAL WITH PAIN. SHE HAD MINOR BLEEDING.