FDA.reportPublic FDA data

MAUDE MDR 7366872

MDR report key
7366872
Report number
9611053-2018-00029
Event key
0
Event type
3
Date received
2018-03-23
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
MRS. HELEN LEWIS
Address
221 W. PHILADELPHIA ST. SUITE 60W YORK PA 17401 US
Phone
717-717-7178
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ROOT FILLER LINSTRUMENT, FILLING, PLASTIC, DENTALDENTSPLY VDW GMBHEIYNAV040393021035179031Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-03-230

Event Narratives#

N

Patient 1

THERE HAS BEEN A PREVIOUS REPORT WITH THE SAME PRODUCT 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

IN THIS EVENT IT WAS REPORTED THAT A PASTE FILLER SEPARATED; NO INJURY RESULTED.

N

Patient 1

ONLY UNUSED PASTE FILLERS WERE RETURNED. INVOLVED PRODUCT THAT BROKE DURING USE IS NOT AVAILABLE AND CANNOT BE ANALYZED. NOTHING UNUSUAL TO REPORT WAS FOUND DURING DHR REVIEW. UNUSED INSTRUMENTS WERE MEASURED AND WERE FOUND IN COMPLIANCE WITH SPECIFICATIONS. FOR INFORMATION, NO MECHANICAL TEST IS APPLICABLE REGARDING THIS PRODUCT. ROOT CAUSES ARE NOT IDENTIFIED. WE WILL TRACK THIS KIND OF EVENT AND MONITOR THE TREND.