MAUDE Adverse Event Report: ULTRADENT PRODUCTS INC/ORATECH LLC BIOTENE MOUTH SPRAY (UNKNOWN); ORAL SPRAY

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Argus case (b)(4).
Event or Problem Description
All other products so not contain sodium saccharin (sweet and low kind of artificial sweetener that cause anaphylaxis to me [anaphylaxis].It almost killed me by allergic reaction to saccharin [impending doom].It almost killed me by allergic reaction / the spray can kill me [allergic reaction].Case description: this case was reported by a consumer via call center representative and described the occurrence of anaphylaxis in a female patient who received glycerin (biotene mouth spray (unknown)) oromucosal spray (batch number unk, expiry date unknown) for dry mouth.Concurrent medical conditions included drug allergy.Concomitant products included glycerin (biotene oral balance gel).On an unknown date, the patient started biotene mouth spray (unknown).On an unknown date, an unknown time after starting biotene mouth spray (unknown) and biotene oral balance gel, the patient experienced anaphylaxis (serious criteria gsk medically significant and other: gsk medically significant), impending doom and allergic reaction.The patient was treated with ambiguous medication nos (epipen (nos)).The action taken with biotene mouth spray (unknown) was unknown.On an unknown date, the outcome of the anaphylaxis, impending doom and allergic reaction were unknown.The reporter considered the anaphylaxis, impending doom and allergic reaction to be related to biotene mouth spray (unknown).Additional information.Adverse event information was received via call center representative (email) on 09 july 2020.Consumer reported that, "good evening, i just wanted to give you some feedback.I recently purchased the dry mouth spray.I love the dry mouth gel but one popped open and smeared the entire contents over everything in my purse (it was messy, it was expensive.Maybe a tighter closing cap?) so i purchase the spray.All other products so not contain sodium saccharin (sweet and low kind of artificial sweetener that cause anaphylaxis to me).I should have checked, it is my fault, but to my knowledge this is the first biotene product with saccharin in it.Long story short, i am out quite a bit of, i'm down one epipen, threw away a purse and keep finding goopy stuff to this day.So not a fan of the spray.Tldr it almost killed me by allergic reaction to saccharin because they do not use it in other products and the gel rocks but does open and spreads goop everywhere, for years.Love the mouthwash and the gel, but cannot use the gel without the mess and the spray can kill me.Have a great day, please consider a new cap for the gel or individual package are great, also, please get rid of saccharin since it is cancer causing and my dad recently passed away from cancer.So please, use splenda.Use stevia.Anything but cancerous chemicals.Please.".

• Brand Name: BIOTENE MOUTH SPRAY (UNKNOWN)
• Common Device Name: ORAL SPRAY
• Manufacturer (Section D): ULTRADENT PRODUCTS INC/ORATECH LLC; south jordan; UT
• MDR Report Key: 10362162
• Report Number: 3012293198-2020-00056
• Device Sequence Number: 2556968
• Product Code: LFD
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K123731
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2020
• Initial Report FDA Received Date: 08/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other