FDA.reportPublic FDA data

MAUDE MDR 9833392

MDR report key
9833392
Report number
2424472-2020-00022
Event key
0
Event type
3
Date received
2020-03-15
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
MR. KARL NITTINGER
Address
221 W. PHILADELPHIA ST. SUITE 60W YORK, PA US
Phone
849-849-8494
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
130K FOCUSED SPRAY SLIMLINE ULTRASONIC INSERT - 10S STRAIGHTSCALER, ULTRASONICDENTSPLY LLCELCNA8039516187N R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-150

Event Narratives#

N

Patient 1

WHILE NO SERIOUS INJURY RESULTED IN THIS EVENT, THERE HAS BEEN A PREVIOUS REPORT RECEIVED WHERE THIS MALFUNCTION RESULTED IN A SERIOUS INJURY. THEREFORE, IT MUST BE PRESUMED THAT RECURRENCE OF THIS MALFUNCTION COULD POSSIBLY CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR REQUIRE MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE SUCH. AS SUCH, THIS EVENT IS REPORTABLE PER 21CFR PART 803. THE DEVICE IS AVAILABLE FOR EVALUATION, THOUGH RESULTS ARE NOT AVAILABLE AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

D

Patient 1

WHILE USING A 30K FSI-SLI-10S INSERT, THE INSERT OVERHEATS; NO INJURY RESULTED.