FDA.reportPublic FDA data

MAUDE MDR 15185

MDR report key
15185
Report number
MW1003069
Event key
0
Event type
3
Date of event
1994-06-23
Date received
1994-08-11
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
401
Health professional
3
Initial report to FDA
0
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1INNERVATORFISHER & PAYKEL HEALTHCAREKOINS-252NANAN*

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
11994-08-1101. O

Event Narratives#

D

Patient 1

BOTH PROXIMAL AND DISTAL JACK RECEPTACLES COME LOOSE WHEN REMOVING THE LEADWIRES. THIS EXPOSES THE INTERNAL WIRES, MAKING IT A POTENTIAL SHOCK HAZARD FOR THE USER. THIS TYPE RECEPTACLE NORMALLY HAS A "D" STYLE MOUNT TO PREVENT SUCH TWISTING. HOWEVER, IT IS NOT PRESENT IN THIS DEVICE.