FDA.reportPublic FDA data

MAUDE MDR 242135

MDR report key
242135
Report number
1419218-1999-00002
Event key
0
Event type
3
Date of event
1999-09-08
Date received
1999-09-23
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#

Address
5312 N. ELSTON AVE CHICAGO IL 60630 US
Phone
773-773-7732
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1EXONIX ULTRASONIC SURGICAL SYSTEMULTRASONIC DIATHERMYFIBRA-SONICSIMIEXONIX*NIK915557NRN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
11999-09-2301. O

Event Narratives#

D

Patient 1

DOCTOR RECEIVED A SECOND DEGREE BURN ON THE BACK OF HIS HAND (SIZE UNK), WHEN HE TOUCHED THE DEVICE APPLICATOR TO BACK OF HIS HAND TO TEST HOW HOT THE APPLICATOR HAD BECOME.