inforMED
MalfunctionGAF

DISPOSABLE MIXING BOWL AND SPATULA

Received Nov 23, 2011 · Event occurred Oct 19, 2011

Report 1822565-2011-02602 · MDR key 2395150

Device

Manufacturer

Zimmer Inc

Catalog number

00504901100

Lot number

61714950

Product problems

  • Device Contamination with Chemical or Other Material

Patient

Not reported

  • No Consequences Or Impact To Patient

Narrative

Description of Event or Problem

IT WAS REPORTED THAT A FOREIGN SUBSTANCE WAS FOUND INSIDE THE DISPOSABLE MIXING BOWL WHEN THE NURSE OPENED THE STERILE POUCH.

Additional Manufacturer Narrative

THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.