FDA.reportPublic FDA data

MAUDE MDR 5945345

MDR report key
5945345
Report number
3005706359-2016-00002
Event key
0
Event type
3
Date of event
2016-05-25
Date received
2016-09-13
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
MS MIKKI DAVIS
Address
1665 LAKES PARKWAY SUITE 102 LAURENCEVILLE 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-4035P014R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-09-1301. H

Event Narratives#

N

Patient 1

THIS REPORT WAS NOT FILED WITHIN THIRTY (30) DAYS OF BECOMING AWARE OF INFORMATION INCLUDED HEREIN DUE TO DELAYS IN THE EMDR REGISTRATION PROCESS. THIS REPORT WAS SUBMITTED AS SOON AS EMDR REGISTRATION WAS COMPLETE.

D

Patient 1

SURGEON REPORTED THAT IT WAS THE USE OF IRRISEPT DURING A PRIMARY TOTAL KNEE REPLACEMENT THAT MAY HAVE CAUSED KNEE PAIN AND WOUND DAMAGE. IT WAS REPORTED THAT THE PATIENT RETURNED TO THE EMERGENCY ROOM POSTOPERATIVE DAY 4 AND WAS DIAGNOSED WITH CELLULITIS IT WAS REPORTED THAT THE PATIENT UNDERWENT A REOPERATION. IT WAS REPORTED THAT THE REOPERATION WAS DONE WITH WASHOUT AND NOT THE DEVICE. ACCORDING TO INFORMATION PROVIDED TO IRRIMAX, SURGEON REPORTING THIS EVENT HAD ANOTHER PATIENT WITH KNEE PAIN AND WOUND DAMAGE WHO HAD UNDERGONE A PRIMARY TOTAL KNEE REPLACEMENT VISIT THE EMERGENCY ROOM ON THE SAME DAY AS THIS PATIENT (MFR REPORT# 3005706359-2016-00001).

N

Patient 1

THIS REPORT WAS NOT FILED WITHIN THIRTY (30) DAYS OF BECOMING AWARE OF INFORMATION INCLUDED HEREIN DUE TO DELAYS IN THE EMDR REGISTRATION PROCESS. THIS REPORT WAS SUBMITTED AS SOON AS EMDR REGISTRATION WAS COMPLETE. IRRIMAX IS SUBMITTING THIS REPORT IN ACCORDANCE WITH 21C.F.R. ? 803. THIS REPORT IS BASED UPON INFORMATION PROVIDED TO IRRIMAX, WHICH IRRIMAX MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THIS REPORT WAS SUBMITTED. IRRIMAX WILL CONTINUE TO CONTACT THE REPORTING PHYSICIAN FOR THE PURPOSE OF OBTAINING ADDITIONAL INFORMATION, TO THE EXTENT POSSIBLE, AND WILL TAKE STEPS TO IDENTIFY OTHER MISSING INFORMATION THAT WILL, TO THE EXTENT APPLICABLE, BE INCLUDED IN A FOLLOW-UP REPORT.

D

Patient 1

SURGEON REPORTED THAT IT WAS THE USE OF IRRISEPT DURING A PRIMARY TOTAL KNEE REPLACEMENT THAT MAY HAVE CAUSED KNEE PAIN AND WOUND DAMAGE. IT WAS REPORTED THAT THE PATIENT RETURNED TO THE EMERGENCY ROOM POSTOPERATIVE DAY 4 AND WAS DIAGNOSED WITH CELLULITIS. IT WAS REPORTED THAT THE PATIENT UNDERWENT A REOPERATION. IT WAS REPORTED THAT THE REOPERATION WAS DONE WITH WASHOUT AND NOT THE DEVICE. ACCORDING TO INFORMATION PROVIDED TO IRRIMAX, SURGEON REPORTING THIS EVENT HAD ANOTHER PATIENT WITH KNEE PAIN AND WOUND DAMAGE WHO HAD UNDERGONE A PRIMARY TOTAL KNEE REPLACEMENT VISIT THE EMERGENCY ROOM ON THE SAME DAY AS THIS PATIENT (MFR REPORT# 3005706359-2016-0001).