FDA.reportPublic FDA data

MAUDE MDR 7776884

MDR report key
7776884
Report number
1045254-2018-00365
Event key
0
Event type
3
Date of event
2018-07-11
Date received
2018-08-13
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
URIZA SHUMS
Address
6743 SOUTHPOINT DR. N. JACKSONVILLE FL 32216 US
Phone
904-904-9043
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1NIM-ECLIPSE? ELECTRODEELECTRODE, NEEDLEMEDTRONIC XOMED INC.GXZNRE1003NRE1003170731002N N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-08-1301. O

Event Narratives#

N

Patient 1

NO ANALYSIS WAS PERFORMED AS THE DEVICE HAS NOT BEEN RETURNED AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED IF THE DEVICE OR COMPONENT IS RETURNED AT A LATER DATE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

D

Patient 1

A HEALTHCARE PROFESSIONAL REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT THE PATIENT SUFFERED A THIRD DEGREE BURN ON THE RIGHT ILIAC CREST AT THE LOCATION OF THE GROUNDED PLATE. MEDICAL HISTORY OF THE PATIENT INCLUDED PENICILLIN ALLERGY, AND NO SMOKING, ALCOHOL, OR DRUGS. IT WAS NOTED THAT THE DEVICE WAS DISCARDED BY THE CUSTOMER.

N

Patient 1

IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

D

Patient 1

ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE INDICATED THAT THE BURN WAS AROUND FIVE SQUARE CENTIMETERS. THEY DIDN'T KNOW WHAT WAS DONE TO TREAT THE BURN OR IF THE PATIENT RECOVERED WITHOUT SEQUELA. THE BURN WAS DISCOVERED AFTER THE SURGERY IN THE PATIENT ROOM. THEY DIDN'T KNOW IF ELECTROSURGICAL EQUIPMENT WAS BEING USED. THE COMPONENTS OF THE SYSTEM WERE PUT IN THE RUBBISH AND THE NURSE WASN'T SURE ABOUT THE SERIAL NUMBER OF THE EQUIPMENT.