FDA.reportPublic FDA data

MAUDE MDR 6472663

MDR report key
6472663
Report number
3003959465-2017-00001
Event key
0
Event type
3
Date received
2017-04-07
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
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
1V3 RING UNIVERSALINSTRUMENTS, DENTAL HANDDENTSPLY (N.Z.) LIMITEDDZNNA403344UNKR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-04-0701. R

Event Narratives#

N

Patient 1

THEREFORE, BECAUSE MEDICAL INTERVENTION WAS REQUIRED TO PRECLUDE A SERIOUS INJURY, THIS EVENT IS REPORTABLE PER 21CFR PART 803. 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 V3 TRIODENT UNIVERSAL RING WAS SWALLOWED BY A PATIENT DURING A DENTAL PROCEDURE. THE CLINICIAN DID NOT USE A RUBBER DAM AS RECOMMENDED PER THE IFU. THE PATIENT WAS SENT TO A GI SPECIALIST WHO RETRIEVED THE RING WITH AN ENDOSCOPE.