inforMED
InjuryEFS

CONAIR

Received Mar 7, 2022 · Event occurred Jul 1, 2020

Report 1222304-2022-00005 · MDR key 13683425

Device

Generic name

Oral Irrigator

Manufacturer

Conair Llc.

Model number

SWJ2

Product problems

  • Fungus in Device Environment

Patient

Unknown

  • Insufficient Information
  • Insufficient Information

Narrative

Additional Manufacturer Narrative

03/07/2022 - OUR RISK MANAGEMENT CONTACTED THE CONSUMER. SINCE THE INCIDENT OCCURED (B)(6) 2020 AND WAS NOT ADDRESSED UNTIL 2/9/2022, THE CONSUMER DISCARDED THE DEVICE. THEREFORE AN INVESTIGATION WILL NOT OCCUR.

Description of Event or Problem

3/7/2022 - PER OUR CUSTOMER SERVICE DEPARTMENT. THE INCIDENT OCCURRED ON (B)(6) OF 2020 BUT WASN'T ADDRESSED UNTIL 2/9/2022. THE CONSUMER CLAIMS TO HAVE GOTTEN SICK DUE TO MOLD INSIDE THE DEVICE'S TUBE AND TIP. THE DONSUMER DISCARDED THE DEVICE. THEREFORE AN INVESTIGATION WILL NOT OCCUR.