inforMED
InjuryEHK

CRESCENT RINN A DIVISION OF DENTSPLY

Received Feb 25, 2004

Report MW1031339 · MDR key 514804

Device

Generic name

R.a. Webbed Cups

Model number

PRODUCT #C200030

Catalog number

*

Lot number

*

Product problems

  • Detachment Of Device Component

Patient

*

  • No Consequences Or Impact To Patient

Narrative

Description of Event or Problem

RUBBER CUP POPS OFF FROM THE PLASTIC SHAFT IF THE PT EVEN BITES LIGHTLY ON THIS ATTACHMENT CAUSING EITHER A CHOKING OR ASPIRATION RISK. THERE WAS NO INJURY TO PT, BUT REPORTER IS CONCERNED THAT A HIGH RISK IS POSSIBLE IF THE CAP COMES OFF.