MADAJET XL

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-08-07 for MADAJET XL manufactured by Mada Medical Products, Inc..

Event Text Entries

[17801516] 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW4003067
• MDR Report Key: 347870
• Date Received: 2001-08-07
• Date of Report: 2001-08-07
• Date of Event: 2001-04-01
• Date Added to Maude: 2001-08-22
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: MADAJET XL
• Generic Name: SUBCUTANEOUS NEEDLELESS INJECTION SYSTEM
• Product Code: EGM
• Date Received: 2001-08-07
• Model Number: NA
• Catalog Number: NI
• Lot Number: 011690XLD
• ID Number: PURCHASE DATE 4/1/2001
• Device Availability: *
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 337193
• Manufacturer: MADA MEDICAL PRODUCTS, INC.
• Manufacturer Address: 625 WASHINGTON AVE CARLSTADT NJ 07072 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2001-08-07