inforMED
OtherGXB

NEUROTIP

Received Oct 22, 2003 · Event occurred Aug 13, 2003

Report 8021764-2003-00004 · MDR key 491367

Device

Generic name

Neurological Examination Pin

Manufacturer

Owen Mumford, Ltd.

Model number

*

Catalog number

NT540SCA000

Lot number

N0097

Product problems

  • Unknown (for use when the device problem is not known)

Patient

*

  • Allergic reaction

Narrative

Description of Event or Problem

NEUROTIP WAS BEING USED TO ASSESS LOWER LIMB SENSATION. PT RETURNED TO CLINIC HALF AN HOUR LATER EXPERIENCING THE BEGINNING OF AN ALLERGIC REACTION. MFR WAS CONTACTED BY THE HEALTHCARE PROFESSIONAL IN CHARGE WHO WAS ADVISED OF THE MATERIAL QUANTITIES THAT MAKE UP THE CONTENT OF THE STEEL. IT WAS THEN MENTIONED BY CO'S 'NEW PRODUCT DESIGN MANAGER' THAT NICKEL COULD BE THE OFFENDING MATERIAL. IT WAS NOTED THAT THE PT HAS MANY ALLERGIES AND IS NOT KNOWN TO HAVE A SPECIFIC ALLERGY TO NICKEL.