FDA.reportPublic FDA data

MAUDE MDR 7861330

MDR report key
7861330
Report number
3005706359-2018-00001
Event key
0
Event type
3
Date of event
2018-07-26
Date received
2018-09-10
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-403R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-09-1001. 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. BLANK FIELDS INDICATE THAT THE INFORMATION WAS NOT PROVIDED BY PHYSICIAN REPORTING THE EVENT, WAS NOT AVAILABLE, OR WAS NOT APPLICABLE. 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

PATIENT EXPERIENCED EKG CHANGE.