inforMED
MalfunctionOGQ

DISPOSABLE EAR WASHER TIPS

Received Apr 3, 2023 · Event occurred Jan 31, 2023

Report 16662693 · MDR key 16662693

Device

Generic name

Ear Irrigation Kit

Catalog number

TW

Lot number

NOT KNOWN

Product problems

  • Break
  • Detachment of Device or Device Component

Patient

6570 DA · Female

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

Narrative

Description of Event or Problem

THE RHINO ELEPHANT EAR WASHER SINGLE USE TIP, DETACHED FROM ORIGINAL ATTACHMENT PIECE CONNECTING TO ELEPHANT SPRAY WASHER WHICH BROKE OFF IN PATIENT'S EAR. THE PHYSICIAN WAS ADVISED, AND HE WAS ABLE TO REMOVE THE PLASTIC TIP WITH FORCEPS. NO OTHER CONCERNS OR HARM TO THE PATIENT PER PHYSICIAN. MANUFACTURER RESPONSE FOR EAR WASHER TIP, DISPOSABLE EAR WASHER TIPS (PER SITE REPORTER) E-MAIL TO VENDOR.