FDA.reportPublic FDA data

MAUDE MDR 2474227

MDR report key
2474227
Report number
2022474-2012-00003
Event key
0
Event type
3
Date received
2012-02-28
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Address
P.O. BOX 13398 RESEARCH TRIANGLE PARK NC 27709 US
Phone
888-888-8888
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1BIOTENE ORAL RINSEGLUCOSE OXIDASE+LACTOFERRIN+LACTOPEROXIDGLAXOSMITHKLINENTONANAUNKR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12012-02-2801. O

Event Narratives#

D

Patient 1

THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF TASTE ABSENT IN A (B)(6) MALE PT WHO RECEIVED GLUCOSE OXIDASE+LACTOFERRIN+LACTOPEROXIDASE+LYSOZYME (BIOTENE ORAL RINSE) FOR AN UNK DRUG INDICATION. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. ON AN UNK DATE, THE PT STARTED GLUCOSE OXIDASE+LACTOFERRIN+LACTOPEROXIDASE+LYSOZYME. AT AN UNK TIME AFTER STARTING GLUCOSE OXIDASE+LACTOFERRIN+LACTOPEROXIDASE+LYSOZYME, THE PT EXPERIENCED TASTE ABSENT AND TASTE ALTERATION. AT THE TIME OF REPORTING, THE EVENTS WERE UNRESOLVED. F/U WAS RECEIVED ON (B)(4) 2012 WHICH UPGRADED THE CASE TO SERIOUS: THE CONSUMER CALLED IN AND REPORTED THE ORIGINALLY REPORTED ADVERSE EVENTS OF LOST SENSE OF TASTE AND ALTERED SENSE OF TASTE AND WAS NOT DUE TO USING THE ORIGINALLY REPORTED PRODUCT OF BIOTENE DRY MOUTH ORAL RINSE. IT WAS DETERMINED WHEN HIS WIFE WHO IS A NURSE WAS CONCERNED IT MAY BE SOMETHING MORE SERIOUS AND HE WENT TO THE HOSP WHERE THEY DID CONFIRM HE WAS HAVING SIGNS OF A STROKE COMING ON.

N

Patient 1

BIOTENE ORAL RINSE IS MFG IN (B)(4), IN THE US, AND NEITHER THE PRODUCT NOR LOT NUMBER FOR THIS PRODUCT IS AVAILABLE. (B)(4).