inforMED
OtherCBH

B7048 - TUBE RESTRAINT

Received Sep 25, 2001 · Event occurred Jan 1, 1994

Report 1647162-2001-00002 · MDR key 354268

Device

Generic name

Endotracheal Tube Securing Device

Manufacturer

Ergomed, Inc.

Model number

B7048

Catalog number

B7048-TUBE RESTRAINT

Lot number

*

Product problems

  • Loose

Patient

*

  • Unknown (for use when the patient's condition is not known)

Narrative

Description of Event or Problem

ON A MARKETING TELEPHONIC INQUIRY, FROM ERGOMED, INC. AN RN AT A HOSPITAL INDICATED THE B7048 TUBE RESTRAINT WAS NOT "HOLDING" "TO THE PT'S SKIN PROPERLY". THE INQUIRER WAS MISTAKEN AS THE TUBE RESTRAINT HAS NO ADHESIVE. THE REPORTER EXPLAINED THIS TO THE INQUIRER AND THE INQUIRER SAID "WASN'T INTERESTED" IN THIS PRODUCT.

Remedial action

  • Other