FDA.reportPublic FDA data

MAUDE MDR 8218643

MDR report key
8218643
Report number
9615332-2019-00004
Event key
0
Event type
3
Date received
2019-01-04
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Address
PO 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 RINSE (UNSPECIFIED VARIANT)ORAL RINSESKIK CUSTOM PRODUCTSLFDUNKNOWNR *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-01-0401. O

Event Narratives#

N

Patient 1

MFR REPORT IS ASSOCIATED WITH ARGUS CASE (B)(4), BIOTENE ORAL RINSE (UNSPECIFIED VARIANT).

D

Patient 1

MY HUSBAND HAD A STROKE AND INSTEAD OF SPITTING THE BIOTENE OUT HE IS SWALLOWING IT [ACCIDENTAL DEVICE INGESTION]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A NURSE AND DESCRIBED THE OCCURRENCE OF ACCIDENTAL DEVICE INGESTION IN A MALE PATIENT WHO RECEIVED GLYCERIN (BIOTENE ORAL RINSE (UNSPECIFIED VARIANT)) MOUTH WASH (BATCH NUMBER UNK, EXPIRY DATE UNKNOWN) FOR DRY MOUTH. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED STROKE. ON AN UNKNOWN DATE, THE PATIENT STARTED BIOTENE ORAL RINSE (UNSPECIFIED VARIANT). ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING BIOTENE ORAL RINSE (UNSPECIFIED VARIANT), THE PATIENT EXPERIENCED ACCIDENTAL DEVICE INGESTION (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE OUTCOME OF THE ACCIDENTAL DEVICE INGESTION WAS UNKNOWN. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE ACCIDENTAL DEVICE INGESTION TO BE RELATED TO BIOTENE ORAL RINSE (UNSPECIFIED VARIANT). ADDITIONAL INFORMATION: ADVERSE EVENT INFORMATION WAS RECEIVED VIA CALL ON 31 DECEMBER 2018. THE CONSUMER REPORTED THAT, "I AM A NURSE AND MY HUSBAND HAD A STROKE AND INSTEAD OF SPITTING THE BIOTENE OUT HE IS SWALLOWING IT. WHAT SYMPTOMS SHOULD I EXPECT? I READ THE INGREDIENTS ON IT ALREADY. IT'S A GOOD PRODUCT AND WE DON'T HAVE AN ISSUE WITH IT, I APPRECIATE IT. I DON'T WANT TO ANSWER ANY QUESTIONS ABOUT THE EXPERIENCE; I JUST WANT TO KNOW WHAT THE POSSIBLE SIDE EFFECTS WOULD BE IF THIS DID HAPPEN."