MADAJET XL
Received Aug 7, 2001 · Event occurred Apr 1, 2001
Report MW4003067 · MDR key 347870
Device
Generic name
Subcutaneous Needleless Injection System
Manufacturer
Mada Medical Products, Inc.Model number
NACatalog number
NI
Lot number
011690XLD
Product problems
- Reaction
Patient
NO INFO
- Pain
- Swelling
Narrative
Description of Event or Problem
NEWLY PURCHASED SUBCUTANEOUS NEEDLE-LESS INJECTION SYSTEM FOR DENTAL USE WAS TRIED (WITH LIDOCAINE) BY DENTIST ON THE FLESHY PART OF PALM PRIOR TO USING ON CHILDREN DENTAL PTS. COMPLAINANT EXPERIENCED IMMEDIATE SEVERE PAIN AND SWELLING AND STILL HAS PAIN IN ARM 4 MONTHS AFTER THE EPISODE. DENTIST DOESN'T THINK THAT THIS IS A DEVICE THAT SHOULD BE USED IN CHILDREN'S MOUTHS. MFR TOLD DENTIST THAT THERE IS NOTHING WRONG WITH THE DEVICE AND THAT THEY PROBABLY HIT A BONE WHEN THEY TRIED IT ON THEIR HAND. WHEN NOT AGAINST ANY OBJECT, THE DEVICE WILL EJECT A LIQUID UP TO 8 FEET WHEN ACTIVATED. UNIT HAS BEEN RETURNED TO MFR.