FDA.reportPublic FDA data

MAUDE MDR 852764

MDR report key
852764
Report number
1823260-2007-01792
Event key
0
Event type
3
Date of event
2007-02-18
Date received
2007-03-02
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
FERN DELACROIX
Address
9115 HAGUE RD. INDIANAPOLIS IN 46250 US
Phone
925-925-9255
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SOFTCLIX PLUS LANCET DEVICELANCET DEVICE - FMKROCHE DIAGNOSTICSFMK*04628349001BAR066NNN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12007-03-020

Event Narratives#

D

Patient 1

CUSTOMER REPORTS LANCET WILL NOT RETRACT. NO ACCIDENTAL NEEDLE STICK OCCURRED. THE CUSTOMER DID NOT PROVIDE THE LOCATION WHERE THE MALFUNCTION OCCURRED. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

N

Patient 1

THE SUSPECT PRODUCT IS THE SOFTCLIX PLUS LANCET.