STROBEX COMPACT S300

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1999-09-17 for STROBEX COMPACT S300 manufactured by Coltene/whaledent.

Event Text Entries

[17904656] Incident date: 08/11/1999. Having a problem with the ground on this machine. A pt was shocked and burned inside her cheek. The dr feels the cause was water seeping in between the sleeve and the head of the handpiece which holds the electrode tip. It happened twice before.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2416455-1999-00001
• MDR Report Key: 240532
• Report Source: 05
• Date Received: 1999-09-17
• Date of Report: 1999-09-16
• Date of Event: 1999-08-11
• Date Mfgr Received: 1999-08-19
• Device Manufacturer Date: 1984-04-01
• Date Added to Maude: 1999-09-21
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: DENTIST
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 0
• Single Use: 3
• Remedial Action: OT
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: STROBEX COMPACT
• Generic Name: DENTIAL ELECTROSURGE
• Product Code: EKZ
• Date Received: 1999-09-17
• Model Number: S300
• Catalog Number: S300
• Lot Number: NA
• ID Number: NA
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: Y
• Implant Flag: Y
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 233061
• Manufacturer: COLTENE/WHALEDENT
• Manufacturer Address: 750 CORPORATE DR. MAHWAH NJ 074302009 US
• Baseline Brand Name: STROBEX COMPACT
• Baseline Generic Name: DENTIAL ELECTROSURGE
• Baseline Model No: S300
• Baseline Catalog No: S300
• Baseline ID: NA

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1999-09-17