FDA.reportPublic FDA data

MAUDE MDR 728001

MDR report key
728001
Report number
3004063246-2006-00004
Event key
0
Event type
3
Date of event
2005-06-15
Date received
2006-05-22
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
BRUCE PROTHRO
Address
680 VAQUEROS AVENUE SUNNYVALE CA 94085 US
Phone
408-408-4087
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1RAPID RHINO SINU KNIT DRESSINGNASAL SPLINTARTHROCARE UK LTDEPPNARR 6002004 07 12GNYR

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12006-05-2201. O

Event Narratives#

D

Patient 1

ON APRIL 19, 2006, A CLINICAL INCIDENT INVOLVING A RAPID RHINO DEVICE WAS REPORTED TO ARTHROCARE CORPORATION. IN 2005, THE PATIENT WAS TREATED WITH A NASAL DRESSING FOLLOWING A SINUS SURGERY. IT WAS REPORTED THE PATIENT HAS HAD RECURRENT INFECTIONS DURING THE SIX MONTHS FOLLOWING TREATMENT WITH THE NASAL DRESSING.

N

Patient 1

A PORTION OF THE DEVICE WAS RETURNED FOR EVALUATION. THE SAMPLE RECEIVED DID NOT MEET THE MATERIAL REQUIREMENTS FOR THE DEVICE. A RETENTION SAMPLE FROM THE SAME LOT WAS ALSO ANALYZED AND MET THE MATERIAL REQUIREMENT FOR THE DEVICE. THE INSTRUCTIONS FOR USE PROVIDES THE FOLLOWING INSTRUCTIONS AT THE POSTOPERATIVE VISIT. "ANY RESIDUAL GEL THAT HAS NOT DISSOLVED OR LEFT THE SURGICAL SITE THROUGH NORMAL OUTFLOW PASSAGES MAY BE EASILY REMOVED THROUGH GENTLE SUCTION". BASED ON THIS INFORMATION, IT WAS CONCLUDED THE DEVICE WAS NOT PROPERLY REMOVED FOLLOWING THE PROCEDURE. THE EVENT OCCURRED DUE TO USER ERROR.