FDA.reportPublic FDA data

MAUDE MDR 9653754

MDR report key
9653754
Report number
MW5092664
Event key
0
Event type
3
Date of event
2020-01-14
Date received
2020-01-30
Adverse event
3
Product problem
0
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1LUX M05LHANDPIECE, AIR-POWERED, DENTALKAVO DENTAL / KALTENBACH & VOIGTEFBLUX M05LI Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-01-300

Event Narratives#

D

Patient 1

SMALL BURN OCCURRED THROUGH DRY ANGLE MATERIAL AFTER DENTAL RESTORATION USING NEW HANDPIECE. FDA SAFETY REPORT ID# (B)(4).