MalfunctionDYN

EURONDA

Received Oct 1, 2003

Report MW1029799 · MDR key 490615

Device

Generic name

Flexible Saliva Extractor

Manufacturer

Euronda Spa

Model number

CF368

Catalog number

Lot number

221101

Product problems

Device Maintenance Issue

Patient

39 YR

Tissue Damage

Narrative

Description of Event or Problem

ADD'L INFO REC'D FROM MFR 03/26/04: THE SALIVA EJECTORS WAS INCORRECTLY USED. THE SALIVA EJECTOR IS A PLASTIC TUBE WITH A GLUED PLASTIC TIP. INSIDE THE TUBE THERE'S A METAL TUBE WHICH MAINTAINS THE SHAPE. THE SALIVA EJECTOR HAS TO BE USED COMPLETE WITH THE CUP, BUT SURELY IN THIS CASE THE DENTIST USED IT WITHOUT CUP IN ORDER TO HAVE A GREATER ASPIRATION. THEREFORE IT'S NOT CO'S RESPONSIBILITY.

Description of Event or Problem

WHILE USING A EURONDA FLEXIBLE SALIVA EJECTOR THE METAL INSIDE THE DEVICE PROTRUDED THROUGH THE FRONT CAUSING TISSUE DAMAGE TO THE PT'S MOUTH. LOT NUMBER CF 368 221101.