FDA.reportPublic FDA data

MAUDE MDR 6152222

MDR report key
6152222
Report number
1722021-2016-00002
Event key
0
Event type
3
Date of event
2015-08-03
Date received
2016-12-07
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
600
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR. MARK DZENDZEL
Address
1717 WEST COLLINS AVENUE ORANGE CA 92867 US
Phone
714-714-7145
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1CAVICIDESURFACE DISINFECTANTMETREX RESEARCHLRJR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-12-0701. H; 2. O

Event Narratives#

N

Patient 1

A COMPLAINANT ALLEGED THAT HE HAD EXPERIENCED A CHEMICAL BURN AND AN INTENSE BURNING PAIN FROM EXPOSURE TO CAVICIDE. THE COMPLAINANT ALLEGED THAT A DOCTOR AND A NURSE IN THE EMERGENCY ROOM AT UNIVERSITY MEDICAL CENTER (UMC) HAD SPRAYED CAVICIDE DIRECTLY INTO HIS OPEN WOUND MULTIPLE TIMES BEFORE SUTURES WERE APPLIED. THE SEVERE BURNING PAIN INCREASED IN INTENSITY AS MORE CAVICIDE SPRAY WAS APPLIED TO THE OPEN WOUND. IT WAS NOTED THAT THE COMPLAINANT RETURNED TO THE EXAMINATION ROOM AND DEMANDED TO HAVE THE SUTURES REMOVED AND HIS WOUND RINSED. THE HOSPITAL STAFF REMOVED THE SUTURES, RINSED THE WOUND WITH WATER AND RE-SUTURED IT. LIDOCAINE WAS APPLIED TO THE WOUND. DAYS LATER, THE COMPLAINANT WENT TO THE (B)(6) BURN UNIT AND WAS REPORTED THAT HE DID OBTAIN SATISFACTORY TREATMENT THERE. THE PRODUCT INVOLVED IN THE ALLEGED INCIDENT WAS NOT RETURNED AND NO LOT WAS PROVIDED; THEREFORE, NO INVESTIGATION CAN BE CONDUCTED.

D

Patient 1

A PATIENT HAD EXPERIENCED A CHEMICAL BURN AND AN INTENSE BURNING PAIN FROM EXPOSURE TO CAVICIDE. THE COMPLAINANT ALLEGED THAT A DOCTOR AND A NURSE IN THE EMERGENCY ROOM AT UNIVERSITY MEDICAL CENTER (UMC) HAD SPRAYED CAVICIDE DIRECTLY INTO HIS OPEN WOUND MULTIPLE TIMES BEFORE SUTURES WERE APPLIED.