FDA.reportPublic FDA data

MAUDE MDR 8503377

MDR report key
8503377
Report number
3006524618-2019-00178
Event key
0
Event type
3
Date of event
2019-02-20
Date received
2019-04-11
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
JIM GONZALES
Address
7000 WEST WILLIAM CANNON DRIVE AUSTIN TX 78735 US
Phone
512-512-5123
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
17.5CM ANTERIOR/POSTERIORBALLOON, EPISTAXISARTHROCARE CORP.EMXRR 750UNKNOWNR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-04-1101. O

Event Narratives#

N

Patient 1

(B)(6).

D

Patient 1

IT WAS REPORTED THAT DURING A TREATMENT, THE BLUE SHEATH OF RAPID RHINO WAS NOT REMOVED PRIOR TO INSERTION, PRODUCING SEPTAL ABRASION AND EXACERBATION OF EPISTAXIS IN THE PATIENT. THE PACKING THAT WAS DONE WITH THE BLUE SHEATH ON WOULD NOT HAVE BEEN IN THAT LONG AS WHEN AN ENT DOCTOR IDENTIFIED THIS AND REMOVED IT. PATIENT WAS PACKED AGAIN USING A DISSOLVABLE PACKING, THEN CAUTERISED AND PACKED WITH NASOPORE, THEN WENT HOME.