FDA.reportPublic FDA data

MAUDE MDR 1943547

MDR report key
1943547
Report number
8021764-2010-00004
Event key
0
Event type
3
Date of event
2010-11-03
Date received
2010-12-03
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
PETTY 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 PENTIPSUNIFINE PENTIPSOWEN MUMFORD, LTD.FMIAN 35300910742.A600R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12010-12-0301. O

Event Narratives#

D

Patient 1

THE USER STATED: HE INJECTED HIMSELF YESTERDAY MORNING & THE NEEDLE DETACHED IN HIS BODY. HE STATED HE WENT TO THE ER & THE NEEDLE WAS FOUND VIA IMAGING; REFERRED TO SURGEON. SURGEON UNABLE TO REMOVE NEEDLE. HE HAS AN ALTERNATIVE WAY OF ADMINISTERING HIS INULIN.

N

Patient 1

WE ARE AWAITING THE RETURN OF THE PRODUCT AND A QUESTIONNAIRE SENT TO THE PT IN ORDER TO GATHER MORE DETAILS ABOUT THE EVENT.