FDA.reportPublic FDA data

MAUDE MDR 8146087

MDR report key
8146087
Report number
3005581270-2018-00014
Event key
0
Event type
3
Date of event
2018-11-28
Date received
2018-12-10
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MISS LOUISE CALLANAN
Address
IDA BUSINESS PARK GORT GALWAY, CONNAUGHT H91PD EI
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1DANTEC CONCENTRIC NEEDLE ELECTRODEDANTEC DISPOSABLE CONCENTRIC NEEDLENATUS MANUFACTURING LTD.IKT9013S00129013S001225B/18/DY R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-12-1001. C; 2. O

Event Narratives#

N

Patient 1

WORK ORDER HAS BEEN OBTAINED AND WILL BE REVIEWED. DEFECT PARTS HAVE BEEN REQUESTED TO BE RETURNED. CUSTOMER INFORMED NATUS THAT THEY WILL BE RETURNING 11 BOXES OF NEEDLES OF THE SAME LOT NUMBER AND THE CABLE USED. IT IS UNKNOWN IF THE DEFECT NEEDLE IS BEING RETURNED FROM THE CUSTOMER AT THIS TIME.

D

Patient 1

HUB SEPARATION OCCURRED; RESULTED IN A NEEDLE STICK TO THE DOCTOR. FAULTY PRODUCT: (B)(4) LOT 25B/18/D NEEDLE ISSUE. DEFECT NEEDLE, AFTER THE PLASTIC BODY WAS SEPARATED FORM THE NEEDLE, THE NEEDLE BIT PRICK WAS ALONE AT THE END OF THE CABLE EMG. THE DOCTOR STUNG HIMSELF BY REMOVING THE NEEDLE.