FDA.reportPublic FDA data

MAUDE MDR 8449612

MDR report key
8449612
Report number
8021764-2019-00005
Event key
0
Event type
3
Date received
2019-03-25
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
1UNIFINE PENTIPSPEN NEEDLESOWEN MUMFORD LTDFMIAN 35401808751.V642R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-03-2501. O

Event Narratives#

D

Patient 1

WIFE CALLED ON BEHALF OF HUSBAND WHO HAD PEN NEEDLE BRAND SWITCHED BY PHARMACY. HUSBAND COMPLAINING OF BENT AND BROKEN NEEDLES. NEEDLE HAS BROKEN OFF IN SKIN, THOUGH WIFE WAS ABLE TO REMOVE IT AND TEND THE AREA AS NECESSARY. WIFE SAYS HUSBAND DOES NOT LEAVE PEN NEEDLE ON PEN, NOR DOES HE REUSE THE NEEDLE. DATE OF BROKEN NEEDLE IN SKIN WAS NOT GIVEN.