inforMED
InjuryOGQ

WAX BLASTER MD

Received Dec 29, 2022 · Event occurred Nov 25, 2022

Report 3013559620-2022-00001 · MDR key 16071385

Device

Generic name

Ear Rinse System

Manufacturer

Eosera Inc.

Catalog number

WBMD

Lot number

X223123

Product problems

  • Patient Device Interaction Problem
  • Patient Device Interaction Problem

Patient

40 YR · Male

  • Ear Pain
  • Ear Pain

Narrative

Description of Event or Problem

(B)(6) USED OUR PRODUCT AND SELF-DIAGNOSED HIS PERFORATED EAR DRUM. AT THE TIME OF CONTACTING EOSERA (B)(6) 2022 HE STATED HE IS FINE NOW. HE STATED THAT HE HAD SEEN A DOCTOR WHO CONFIRMED HIS PERFORATED EAR DRUM. HE HAD ALSO STATED HE USED IT ON HIS CHILDREN WHO HAD NO PROBLEMS. UPON MEDICAL SAFETY FOLLOW-UP CALL ON 12/04/2022 BY OUR MEDICAL SAFETY OFFICER, (B)(6) REPEATED THAT HE HAD NO FURTHER PROBLEMS.

Additional Manufacturer Narrative

EAR SYRINGING IS A COMMON CLINICAL PROCEDURE IN PRIMARY HEALTH CARE AND THERE ARE MANY AT HOME SYRINGES AVALIABLE.