FDA.reportPublic FDA data

MAUDE MDR 852758

MDR report key
852758
Report number
1823260-2007-01798
Event key
0
Event type
3
Date of event
2006-12-07
Date received
2007-03-02
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
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*04628349001BAS031NYR

Patients#

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

Event Narratives#

D

Patient 1

CUSTOMER REPORTS THE SOFTCLIX LANCET WILL NOT PRICK HER FINGER. NO ACCIDENTAL NEEDLE STICK OCCURRED. THE CUSTOMER DID NOT PROVIDE THE LOCATION WHERE THE MALFUNCTION OCCURRED. NO ADVERSE EVENT REPORTED. UPON EVALUATION BY THE MANUFACTURER, IT WAS CONFIRMED THAT THE LANCET WILL NOT RETRACT. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT. SOFTFLIX LANCET LOT NUMBER BAS031.

N

Patient 1

THE SUSPECT PRODUCT IS THE SOFTCLIX PLUS LANCET.