GENTLEPOWER LUX CONTRA ANGLE 25LPA 1002.1526

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-06-19 for GENTLEPOWER LUX CONTRA ANGLE 25LPA 1002.1526 manufactured by Kaltenbach & Voigt Gmbh.

Event Text Entries

[17372006] Head of handpiece overheated and caused burn to pt's cheek.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1419798-2008-00010
• MDR Report Key: 1065757
• Date Received: 2008-06-19
• Date of Report: 2008-05-22
• Date of Event: 2008-05-14
• Date Facility Aware: 2008-05-22
• Report Date: 2008-05-22
• Date Reported to FDA: 2008-06-19
• Date Reported to Mfgr: 2008-05-22
• Date Added to Maude: 2008-06-28
• 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 Sequence Number: 1

• Brand Name: GENTLEPOWER LUX CONTRA ANGLE 25LPA
• Generic Name: DENTAL HANDPIECES
• Product Code: EKK
• Date Received: 2008-06-19
• Returned To Mfg: 2008-05-23
• Model Number: 25LPA
• Catalog Number: 1002.1526
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Age: 2 YR
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 1033164
• Manufacturer: KALTENBACH & VOIGT GMBH
• Manufacturer Address: BISMARCKRING 39 BIBERACH * GM D-88400

Device Sequence Number: 2

• Brand Name: GENTLEPOWER LUX CONTRA ANGLE 25LPA
• Generic Name: ACCESSORIES
• Product Code: EKK
• Date Received: 2008-06-19
• Returned To Mfg: 2008-05-23
• Model Number: 25LPA
• Catalog Number: 1002.1526
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Age: 2 YR
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 1033167
• Manufacturer: KALTENBACH & VOIGT GMBH
• Manufacturer Address: BISMARCKRING 39 BIBERACH * GM D-88400

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2008-06-19