FDA.reportPublic FDA data

MAUDE MDR 8364366

MDR report key
8364366
Report number
8021764-2019-00004
Event key
0
Event type
3
Date of event
2019-01-14
Date received
2019-02-22
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
3
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MS. PATRICIA CRONAN
Address
1755 WEST OAK COMMONS CT. MARIETTA GA 30062 US
Phone
770-770-7709
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1UNISTIK 3 COMFORTSAFETY LANCETOWEN MUMFORD LIMITEDFMKAT 104401187Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-02-220

Event Narratives#

N

Patient 1

THE COMPLAINANT REPORTED THAT 3 DEVICES DID NOT RETRACT DURING THE EVALUATION, WHICH WAS PERFORMED BY THE NHS, BUT NOT USED ON HUMANS. ONLY 1 OF THE REPORTED 3 DEVICES NOT RETRACTING WAS RETURNED. THE 1 DEVICE RETURNED WAS TESTED AND THE NEEDLE HAD IN FACT RETRACTED AS IT WAS SUPPOSED TO. [(B)(4)].

D

Patient 1

DURING A SUBMISSION OF UNISTIK 3 FOR EVALUATION STAGE OF BLOOD MINI LANCET MINI COMPETITION, 3 LANCETS OUT OF 80 FAILED; NON-RETRACTING NEEDLES - THIS WAS REPORTED AS A COMPLAINT TO OWEN MUMFORD LIMITED.