FDA.reportPublic FDA data

MAUDE MDR 6715842

MDR report key
6715842
Report number
9614794-2017-00003
Event key
0
Event type
3
Date of event
2017-06-08
Date received
2017-07-14
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
1PINKALGIN 5MATERIAL, IMPRESSIONZHERMACK S.P.A.ELWNAC302140250272R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-07-1401. O

Event Narratives#

N

Patient 1

WHILE IT IS UNKNOWN IF THE DEVICE USED IN THIS CASE CAUSED OR CONTRIBUTED TO THE PATIENT'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. THEREFORE, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR PART 803. PLEASE NOTE THAT WHILE THIS PRODUCT IS NOT SOLD IN THE US, IT IS CONSIDERED SIMILAR TO PRODUCTS THAT ARE MARKETED IN THE US BY DENTSPLY. RETAIN PRODUCT WAS EVALUATED AND FOUND TO BE WITHIN SPECIFICATION. A DHR REVIEW WAS CONDUCTED WITH NO DISCREPANCIES NOTED.

D

Patient 1

IT WAS REPORTED THAT A PATIENT EXPERIENCED AN ALLERGIC REACTION AFTER USE OF PINKALIGN 5 DENTAL IMPRESSION MATERIAL. THE PATIENT HAD A RASH THAT LASTED FOR APPROXIMATELY FIVE DAYS. NO TREATMENT WAS REQUIRED.