FDA.reportPublic FDA data

MAUDE MDR 698120

MDR report key
698120
Report number
698120
Event key
0
Event type
3
Date of event
2006-03-15
Date received
2006-03-29
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
500
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
U
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1THE DENVER SPLINTSPLINT, NASALSHIPPERT MEDICAL TECHNOLOGIES CORPORATIONEPPSERIES 1500 KIT SMALL/MEDIUM10-1500-05K10030NN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12006-03-290

Event Narratives#

D

Patient 1

SURGEON APPLIED DENVER SPLINT AFTER NASAL SURGERY. IT WAS NOTED THAT SMALL AMOUNTS OF THE PAINT FLAKED OFF FROM THE SPLINT ONTO THE PATIENT'S EYE AREA. SURGEON IMMEDIATELY REMOVED ALL OF THE FLAKES USING A SUCTION AND THERE WAS NO INJURY TO THE PATIENT AND THE SURGEON DID NOT WANT THE SPLINT REMOVED. ON 3/23/06, A SURGERY STAFF MEMBER NOTIFIED MANUFACTURER AND MANUFACTURER INDICATED AWARENESS OF FLAKING PROBLEM, HOWEVER THEY BELIEVED IT WAS RESOLVED. MANUFACTURER WILL REPLACE OUR CURRENT STOCK OF SMALL/MEDIUM SPLINTS.