ULTRA SAFETY PLUS XL (27 GAUGE LONG) *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-04-13 for ULTRA SAFETY PLUS XL (27 GAUGE LONG) * manufactured by Sepotodont Sas.

Event Text Entries

[16433297] Spontaneous report, local reference # 201200011. Initial info received on (b)(6) 2012. The dentist reported that a pt (unspecified gender), with no specific medical history, had been treated with ultra safety plus xl 27g long 0. 40x35mm sterile injectable system with protective sheath and handle. On an unspecified date, the pt experienced device failure. The device separated. The cannula stayed in the pt's mouth and was removed by surgery. According to the dentist, the cannula did not break; it became disconnected from the hub. The pt had fully recovered on an unspecified date. No other info is available. This case report is considered serious.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2529586-2012-00002
• MDR Report Key: 2553523
• Date Received: 2012-04-13
• Date of Report: 2012-03-27
• Date Facility Aware: 2012-03-27
• Report Date: 2012-04-13
• Date Reported to FDA: 2012-04-13
• Date Reported to Mfgr: 2012-03-27
• Date Added to Maude: 2012-04-30
• Event Key: 0
• Report Source Code: Distributor report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: DENTIST
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ULTRA SAFETY PLUS XL (27 GAUGE LONG)
• Generic Name: CARTRIDGE SYRINGE
• Product Code: EJI
• Date Received: 2012-04-13
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: SEPOTODONT SAS
• Manufacturer Address: * SAINT MAUR DES FOSSES * 94100 FR * 94100

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2012-04-13