FDA.reportPublic FDA data

MAUDE MDR 25234113

MDR report key
25234113
Report number
8021764-2026-00005
Event key
0
Event type
3
Date of event
2026-03-25
Date received
2026-05-20
Adverse event
1
Product problem
0
Patients in event
0
Reporter occupation
3
Health professional
0
Initial report to FDA
0
Event location
0

Manufacturer Contact#

Contact
MRS. PATTY HANEY
Address
1755 WEST OAK COMMONS CT. MARIETTA GA 30062 US
Phone
770-770-7709
Report source
M

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
14716UNISTIK 3LANCETOWEN MUMFORD LIMITEDFMIP006114A12501100NN
181005UNISTIK 3LANCETOWEN MUMFORD LIMITEDFMIP006114A12501100NN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12026-05-200O

Event Narratives#

D

Patient 0

A CUSTOMER BASED IN IRELAND REPORTED THAT ONE OF THEIR CUSTOMERS REPORTED A PATIENT COMPLAINED THAT A LANCET TOOK A PIECE OF THEIR SKIN OUT OF THEIR FINGER AND LEFT A FRAGMENT OF PLASTIC IN THE SITE, OF WHICH HAD TO BE REMOVED WITH TWEEZERS. THE PATIENT SAID (HE OR SHE) SOUGHT MEDICAL ATTENTION TO ENSURE NO FURTHER FRAGMENTS REMAINED IN THE SITE. NOTHING ELSE WAS REPORTED. THIS WAS REPORTED TO THE UK ON (B)(6) 2026 AND WAS REPORTED TO MHRA. THEIR CUSTOMER THEN REPORTED THAT THE CUSTOMER WHO COMPLAINED WAS IN THE US, ON (B)(6) 2026.

N

Patient 0

50 RETAINED SAMPLES WERE VISUALLY AND FUNCTIONALLY TESTED WITH NO FAULTS IDENTIFIED; ALL SAMPLES FUNCTIONED TO IFU. THESE DEVICES ARE A 16G SAFETY LANCET WITH A STEEL DIAMETER OF 1.5MM, INTENDED FOR INDIVIDUALS THAT REQUIRE A LARGER BLOOD VOLUME. AFTER BLOOD COLLECTION, THE WOUND MAY APPEAR LARGER COMPARED TO OTHER SPECIFICATIONS OF NEEDLE. THE SENSATION OF PAIN MAY ALSO FEEL GREATER. AS NO PRODUCT HAS BEEN RETURNED, IT IS NOT POSSIBLE TO DETERMINE A ROOT CAUSE FOR THIS INCIDENT.