MAUDE MDR 346778

MDR report key
346778
Report number
1038548-2001-00029
Event key
0
Event type
3
Date of event
2001-07-12
Date received
2001-08-10
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
KRISTEN PIATAK
Address
5175 SOUTH ROYAL ATLANTA DRIVE TUCKER GA 30084 US
Phone
770-770-7707
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1CURVED IRIS SCISSORSSCISSORSGENZYME BIOSURGERY A DIVISION OF GENZYME COLRWNA32-0705463011NYY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12001-08-100

Event Narratives#

D

Patient 1

THE REPORTER ALLEGED THAT WHILE CUTTING NASAL MUCOSA, THE DOCTOR NOTICED A PIECE OF THE TIP INSIDE THE NOSE. HE USED FORCEPS TO RETRIEVE. THERE WAS NO PATIENT INJURY.