MAUDE MDR 5441867

MDR report key
5441867
Report number
1941138-2016-00002
Event key
0
Event type
3
Date of event
2013-03-04
Date received
2016-02-17
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
116
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
SARAH MOORE
Address
13705 SHORELINE CT. E. EARTH CITY MO 63045 US
Phone
314-314-3143
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1PURIT ULTRASONIC TANKULTRASONIC TANK BASKETYOUNG DENTAL MANUFACTURING CO 1, LLC.FLGPT300SPT300S* N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-02-1701. O

Event Narratives#

D

Patient 1

A DENTIST CUT HIS HAND ON THE ULTRASONIC CLEANER BASKET. HE SAID THE EDGE WAS VERY SHARP.