FDA.reportPublic FDA data

MAUDE MDR 8452615

MDR report key
8452615
Report number
3009582362-2019-00003
Event key
0
Event type
3
Date received
2019-03-26
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
3
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
BETH PASHKO
Address
30 SOUTH SATELLITE ROAD SOUTH WINDSOR CT 06074 US
Phone
860-860-8606
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1HTR-PEKKFACIAL IMPLANTOXFORD PERFORMANCE MATERIALSKKYPK620905202446-001R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-03-2601. O

Event Narratives#

D

Patient 1

THE SALES REP RECEIVED INFORMATION FROM THE PHYSICIAN THAT SHE PLANS TO REMOVE THE IMPLANT, AS IT WAS INFECTED AGAIN. UPON FOLLOW UP, IT WAS REPORTED THAT THE PATIENT HAD HAD AN INFECTION APPROXIMATELY ONE-WEEK POST OP. AT THAT TIME, THE PATIENT WAS TREATED WITH ANTIBIOTICS AND THE INFECTION WAS THOUGHT TO HAVE BEEN RESOLVED. THE SALES REP WAS UNABLE TO CONFIM WHETHER THIS IS A DIFFERENT TYPE OF INFECTION OR WHEN IT WAS IDENTIFIED. THIS REPORT IS 1 OF 2 AS TWO SEPERATE DEVICES WERE IMPLANATED AT THE SAME TIME.