FDA.reportPublic FDA data

MAUDE MDR 5221366

MDR report key
5221366
Report number
2320721-2015-00023
Event key
0
Event type
3
Date received
2015-11-13
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
1GUTTACORE OBTURATOR (PINK)GUTTA-PERCHADENTSPLY TULSA DENTAL SPECIALTIESEKMNAGCP02026UNKR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-11-130

Event Narratives#

N

Patient 1

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. THIS REPORT IS FOR THE FIRST PATIENT. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE LOT NUMBER WAS NOT PROVIDED FOR RETAINED PRODUCT TESTING AND/OR DHR REVIEW.

D

Patient 1

IT WAS REPORTED THAT A DOCTOR INADVERTENTLY EXTRUDED GUTTACORE BEYOND THE APEX OF TWO PATIENTS; NO INJURY RESULTED.