FDA.reportPublic FDA data

MAUDE MDR 8173564

MDR report key
8173564
Report number
3005581270-2018-00019
Event key
0
Event type
3
Date of event
2018-09-08
Date received
2018-12-18
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
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
1TECA ELITE NEEDLETECA ELITE DISPOSABLE CONCENTRIC NEEDLE ELECTRODENATUS MANUFACTURING LTDIKTS53156S5315645B/17/TR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-12-1801. O

Event Narratives#

N

Patient 1

CUSTOMER HAS REPORTED 3 CASES. ON INITIAL REPORT IT WAS NOT KNOWN IF THE 3 CASES WERE OF THE SAME PART NUMBER AND LOT NUMBER, OR IF THE NEEDLES WERE USED ON THE SAME PATIENT OR 3 DIFFERENT PATIENTS. THIS INFORMATION WAS CLARIFIED BY THE CUSTOMER ON THE (B)(6) 2018. THE 3 INCIDENTS INVOLVED THE PART NUMBER S53156 AND LOT NUMBER 45B/17/T. THIS OCCURRED AFTER USE ON 3 DIFFERENT PATIENTS. THE THREE INCIDENTS WILL BE INVESTIGATED UNDER COMPLAINTS AND ADVERSE EVENT NUMBERS: (B)(4). JUSTIFICATION FOR NOT PROVIDING BELOW INFORMATION AND APPLICABLE SECTIONS: PATIENT INFORMATION - NO PATIENT INJURY INITIALLY REPORTED, DEVICE MALFUNCTION OCCURRED. THIS WILL BE CONFIRMED. SERIAL # - THIS SECTION IS NOT APPLICABLE AS THE MEDICAL DEVICE DOES NOT HAVE A SERIAL NUMBER. THIS SECTION IS NOT APPLICABLE AS THE MEDICAL DEVICE IS NOT IMPLANTABLE. REPROCESSOR NAME AND ADDRESS - THIS SECTION IS NOT APPLICABLE AS THE MEDICAL DEVICE IS NOT A SINGLE-USE DEVICE THAT WAS REPROCESSED OR REUSED ON A PATIENT. IF ACTION REPORTED TO FDA UNDER 21 USC 360I (F), LIST CORRECTION / REMOVAL REPORTING NUMBER - THIS SECTION IS NOT APPLICABLE AS THERE WAS NO ACTION REPORTED UNDER 21USC 360I(F).

D

Patient 1

HUB SEPARATION NEEDLE ISSUE. DEFECTIVE NEEDLES, THE PLASTIC PROTECTOR IS RELEASED WHEN THE CABLE IS DISCONNECTED AND THE NEEDLE REMAINS CONNECTED TO THE NEEDLE HOLDER. CUSTOMER HAS REPORTED 3 CASES.