FDA.reportPublic FDA data

MAUDE MDR 2542937

MDR report key
2542937
Report number
2530069-2012-00007
Event key
0
Event type
3
Date of event
2011-10-26
Date received
2012-04-05
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
ELIZABETH LAZARO
Address
1910 NORTH PENN RD. HATFIELD PA 19440 US
Phone
267-267-2679
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1DENOPTIX QST DIGITAL IMAGING SYSTEMDENTAL IMAGING PROCESSORALARA, INC.EGY20110433350.822.0725R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12012-04-050

Event Narratives#

D

Patient 1

NURSE GOT ELECTRIC SHOCK WHILE SHE PUT THE DRUM INTO THE DENOPTIX, THERE WAS NO PT INVOLVED BUT THE NURSE GOT ELECTRIC SHOCK 3 TIMES.

N

Patient 1

AWAITING INVESTIGATION RESULTS; PRODUCT UNLIKELY TO BE RETURNED. UPON COMPLETION OF INVESTIGATION, A FOLLOW UP REPORT WILL BE SUBMITTED.