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.