FDA.reportPublic FDA data

MAUDE MDR 829837

MDR report key
829837
Report number
1811755-2007-00013
Event key
0
Event type
3
Date of event
2007-03-06
Date received
2007-03-16
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
JENNIFER HOFFMAN
Address
4100 EAST MILHAM AVE KALAMAZOO MI 49001 US
Phone
269-269-2693
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1IMPACTION BUR GUARDGUARD, DISKSTRYKER INSTRUMENTS KALAMAZOOEEJ*2296301000UNKNRN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12007-03-1601. R

Event Narratives#

D

Patient 1

PT RECEIVED A BURN ON THE UPPER LIP FACIAL AREA DURING SURGERY. PRESCRIPTIONS FOR PAIN, ANTIBIOTICS, AND ANTIVIRAL WERE ADMINISTERED.

N

Patient 1

DEVICE WAS NOT RETURNED FOR EVALUATION.