FDA.reportPublic FDA data

MAUDE MDR 3732979

MDR report key
3732979
Report number
3009683512-2014-00001
Event key
0
Event type
3
Date received
2014-03-27
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
HELEN LEWIS
Address
221 W PHILADELPHIA ST STE 60 YORK PA 17401 US
Phone
717-717-7178
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1DENTAURUM TIESBAND, ELASTIC, ORTHODONTICDENTSPLY RAINTREE ESSIX GLENROEECIDENT-2SILUNKR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12014-03-2701. O

Event Narratives#

D

Patient 1

IN THIS EVENT IT WAS REPORTED THAT AFTER THE USE OF ELASTIC LIGATURE TIES, A PT HAD AN ALLERGIC REACTION. FURTHER DETAILS OF THE SYMPTOMS AND EVENT ARE NOT AVAILABLE.

N

Patient 1

WHILE IT IS UNK IF THE DEVICE USED IN THIS CASE CAUSED OR CONTRIBUTED TO THE PT'S SYMPTOMS, IT IS POSSIBLE AS ALLERGIC REACTIONS TO DENTAL MATERIALS ARE KNOWN AND REPORTED, WITH MEDICAL CONSEQUENCES BEING DEPENDENT UPON THE SEVERITY OF THE INDIVIDUAL ALLERGIC RESPONSE AND SUBSEQUENT EXPOSURE TO THE SAME MATERIAL. REPORTABILITY PER 21 CFR PART 803. THE DEVICE WAS NOT RETURNED FOR EVAL AND THE LOT NUMBER WAS NOT PROVIDED FOR RETAINED-PRODUCT TESTING AND/OR DHR REVIEW.