FDA.reportPublic FDA data

MAUDE MDR 6730321

MDR report key
6730321
Report number
3005706359-2017-00001
Event key
0
Event type
3
Date of event
2017-03-29
Date received
2017-07-20
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
MR. JIM DARNELL
Address
1665 LAKES PARKWAY SUITE 102 LAWRENCEVILLE GA 30043 US
Phone
770-770-7708
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1IRRISEPTWOUND CLEANSERIRRIMAX CORPORATIONFQH403IRRISEPT-403SEE SECTION 10 BELOWR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-07-2001. H; 2. O

Event Narratives#

N

Patient 1

IRRIMAX IS SUBMITTING THIS REPORT IN ACCORDANCE WITH 21 CFR ? 803. THIS REPORT IS BASED UPON INFORMATION PROVIDED TO IRRIMAX. IRRIMAX WILL CONTINUE TO CONTACT REPORTING PHYSICIAN AND OTHER SOURCES AS NECESSARY FOR THE PURPOSE OF OBTAINING ADDITIONAL INFORMATION AND WILL, AS NECESSARY, FILE A FOLLOW-UP REPORT.

D

Patient 1

PHYSICIAN REPORTED THAT THE USE OF IRRISEPT DURING AN INDIRECT BIOPSY POSSIBLY COULD HAVE CAUSED SEIZURE(S) AND/OR STROKE(S) IN A PATIENT WITH MOYAMOYA DISEASE. ACCORDING TO NIH, MOYAMOYA DISEASE IS A PROGRESSIVE, OCCLUSIVE DISEASE OF THE CEREBRAL VASCULATURE INVOLVING THE CAROTID ARTERY IN THE SKULL. MOYAMOYA MAY CAUSE TRANSIENT ISCHEMIC ATTACKS, STROKES, ANEURYSMS OR BLEEDING IN THE BRAIN. PHYSICIAN REPORTED THAT THE USE OF IRRISEPT DURING THE INDIRECT BIOPSY OF THE PATIENT WITH MOYAMOYA DISEASE AND THE SEIZURE(S) AND/OR STROKE(S) WERE LIKELY NOT LINKED.