FDA.reportPublic FDA data

MAUDE MDR 495744

MDR report key
495744
Report number
2183620-2003-00038
Event key
0
Event type
3
Date received
2003-11-14
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
PAUL HARTZELL
Address
2575 UNIVERSITY AVE W ST. PAUL MN 55114 US
Phone
651-651-6516
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1OCU-GUARDORBITAL IMPLANT WRAPSYNOVIS SURGICAL INNOVATIONSMTZUNK*UNKYRN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12003-11-1401. R

Event Narratives#

D

Patient 1

PT UNDERWENT ENUCLEATION PROCEDURE (DATE UNK) FOLLOW BY IMPLANTATION OF HYDROXYAPATITE ORBITAL PROSTHESIS IMPLANT ALONG WITH OCU-GUARD ORBITAL IMPLANT WRAP. AT 2 MONTHS POST-IMPLANT, PT PRESENTED WITH EXPOSURE OF IMPLANT, REQUIRING REMOVAL OF THE DEVICE.