inforMED

SHORT TERM SWAB SYSTEM

Received Mar 17, 2015 · Event occurred Feb 13, 2015

Report 4656695 · MDR key 4656695

Device

Generic name

Patient Personal Hygiene Kit

Manufacturer

Sage Products, Llc

Model number

*

Catalog number

6000

Lot number

47301 OR 47020

Product problems

  • Device Contamination with Chemical or Other Material

Patient

*

  • No Information

Narrative

Description of Event or Problem

WHEN OPENING A SEALED CARTON OF THE SAGE # 6000 MOUTH CARE KITS, WE NOTICED IT WAS INFESTED WITH DEAD INSECTS. IT APPEARED NONE WERE IN THE PACKAGES ITSELF, JUST IN THE SHIPPING CONTAINER. WE FEEL THE LOT NUMBER COULD BE EITHER 47020 OR 47301.