FDA.reportPublic FDA data

MAUDE MDR 7822513

MDR report key
7822513
Report number
8021764-2018-00002
Event key
0
Event type
3
Date of event
2018-06-16
Date received
2018-08-28
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 LTDFMKAT1044029946R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-08-2801. O

Event Narratives#

N

Patient 1

THE DEVICE HAS NOT YET BEEN RETURNED TO THE (B)(4) OFFICE. IF AND WHEN IT IS RETURNED, IT WILL BE EVALUATED.

D

Patient 1

THE PURCHASE MANAGER, MRS. (B)(6), FROM THE HOSPITAL IN (B)(6), RECEIVED AN INCIDENT DECLARATION FROM A NURSE. THE INCIDENT OCCURRED THE (B)(6) IN THE SURGERY SERVICE: THE LANCET DIDN'T RETRACT AND THE NURSE HAS BEEN INJURED. THE LANCET USED HAS BEEN DISPOSED OF AND THE NURSE DIDN'T KNOW THE LOT NUMBER. THE NURSE IS SAFE AS SHE KNOWS THE VIRAL LOAD OF THE PATIENT IS NEGATIVE. LAST WEEK, WEEK 29, THE SAME NURSE HAS HAD THE SAME INCIDENT BUT SHE HAS NOT BEEN INJURED. THIS TIME, SHE KEPT THE LANCET USED AND GAVE THE LOT NUMBER TO THE (B)(4) OFFICE. THIS EVENT IS BEING REPORTED AS THE DEVICE IS ALSO SOLD INTO THE US, THOUGH THIS LOT NUMBER WAS NOT DISTRIBUTED IN THE US.