MAUDE Adverse Event Report: GLAXOSMITHKLINE BIOTENE ORAL BALANCE GEL (GLYCERIN) GEL ; SALIVA, ARTIFICIAL

Health Effect - Clinical Code	Choking (2464)
Date of Event	02/28/2012
Type of Reportable Event	Serious Injury
Event or Problem Description
To prevent choking [choking].Using for sjogren's [device use in unapproved indication].Case description: this case was reported by a nurse and described the occurrence of device use in unapproved indication in a (b)(6) year-old female patient who received glycerin (biotene oral balance gel) gel (batch number w7021, expiry date 30th april 2020) for dry mouth and sjogren's.Co-suspect products included glycerin (biotene oral rinse (unspecified variant)) mouth wash (batch number unknown, expiry date unknown) for dry mouth and sjogren's.Concurrent medical conditions included autoimmune disorder, (i have autoimmune issue).On (b)(6) 2012, the patient started biotene oral balance gel.On an unknown date, the patient started biotene oral rinse (unspecified variant).On (b)(6) 2012, 0 min after starting biotene oral balance gel and an unknown time after starting biotene oral rinse (unspecified variant), the patient experienced device use in unapproved indication.Biotene oral balance gel was continued with no change.The action taken with biotene oral rinse (unspecified variant) was unknown.On an unknown date, the outcome of the device use in unapproved indication was unknown.It was unknown if the reporter considered the device use in unapproved indication to be related to biotene oral balance gel and biotene oral rinse (unspecified variant).Additional information: adverse event information was received on 19 february 2019 via live call.Consumer reported that, "i am calling in about biotene lozenges, i have sjogrens use these products.I used them for years.One thing i use at night is a zilomints i put on in my mouth at night and i have a prescription so i could use my (b)(6) credit card.A week ago i went to buy my mints and they were gone instead of my zilomints they are carrying these.I went to fill up my pill box up.But there are some issues.The zilomints have a grey backing on them that's sticking so you could stick it your gums or cheek.The other thing was the zilomint half the this size.They are the small of you chap stick container and so if that did get down in my air way it is not big enough to block my whole air way.I need to sleep with one of these at night i would be dead.But i thought i would let you know i am actually a nurse i have a couple of autoimmune issues.Now i am a little scared.Because i cant do with out and its a lot of issues.I haven't tried it yet.I use the gel and the rinse.I use them all the time.Sjogrens is what i have i don't have the rinses".Follow up information was received on 05 september 2019 via adverse event reporting (aer) form by physician.This case was confirmed as medically significant.Physician reported that" biotene lozenges need to be smaller to prevent choking.On unknown date, the patient started biotene lozenges.Added suspect drug biotene lozenges, event chocking and patient demographics.On unknown date, after starting biotene lozenges, the patient experienced choking and device use in unapproved indication.The action taken with biotene lozenges was unknown.The event of choking consider as medically significant.On an unknown date, the outcome of the choking was unknown.The reporter considered the choking to be related to biotene lozenges.Diagnosis for use: dry mouth, sjogren's syndrome.(b)(4).

• Brand Name: BIOTENE ORAL BALANCE GEL (GLYCERIN) GEL
• Common Device Name: SALIVA, ARTIFICIAL
• Manufacturer (Section D): GLAXOSMITHKLINE; po box 13398; researchtriangle park NC 27709
• MDR Report Key: 9193262
• Report Number: MW5090394
• Device Sequence Number: 3134858
• Product Code: LFD
• Combination Product (Y/N): Y
• Initial Reporter State: KS
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/10/2019
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/11/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 46 YR
• Patient Weight: 74