inforMED

WAXTRACTOR EAR WAX REMOVAL KIT

Received Dec 19, 2018 · Event occurred Sep 17, 2018

Report MW5082377 · MDR key 8186564

Device

Generic name

Waxtractor Ear Wax Removal Kit

Manufacturer

Unk

Product problems

  • Device Dislodged or Dislocated

Patient

66 YR

  • Unspecified Infection
  • Pain
  • Unspecified Infection
  • Pain

Narrative

Description of Event or Problem

I PURCHASED A WAXTRACTOR EAR WAX REMOVAL KIT FROM (B)(6) ON (B)(6) 2018. AFTER USING THIS PRODUCT, THE TIP ATTACHED TO THE HOSE CONNECTED TO THE WATER BOTTLE SHOT INTO MY EAR AFTER SQUEEZING THE BOTTLE TRIGGER. THE TIP LODGED INTO MY EAR CANAL CAUSING A SEVERE AND PAINFUL EAR INFECTION, THAT NOW HAS RESULTED INTO A RINGING IN MY RIGHT EAR. I HAVE CONTACTED BOTH (B)(6) AND KRUWORKS LLC THE VENDOR BUT TO NO AVAIL. DOCUMENT NUMBER: (B)(4). REPORT NUMBER: (B)(4). KRUWORKS LLC. EMAIL KRUWORKS ON (B)(6) 2018.