BIOTENE MOISTURIZING MOUTH SPRAY (2013 FORMULATION)
Report
- Report Number
- 1718912-2017-00015
- Event Type
- Injury
- Date Received
- June 21, 2017
- Report Date
- June 13, 2017
- Manufacturer
- ULTRADENT PRODUCTS INC./ ORATECH LLC
- Product Code
- LFD
- PMA / PMN Number
- K123731
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PATIENT
Narratives
1718912-2017-00015 IS ASSOCIATED WITH ARGUS CASE (B)(4), BIOTENE MOISTURIZING MOUTH SPRAY.
THIS REPORT IS ASSOCIATED WITH ARGUS (B)(4), BIOTENE MOISTURIZING MOUTH SPRAY.
BURNED TONGUE [BURN OF TONGUE]. BURNED MOUTH [BURNED MOUTH]. PAIN [PAIN]. HAVE TOO MUCH MINT IN THEM/THEY ARE VERY STRONG [ORAL DISCOMFORT]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER VIA CALL CENTER REPRESENTATIVE AND DESCRIBED THE OCCURRENCE OF BURN OF TONGUE IN A FEMALE PATIENT WHO RECEIVED GLYCERIN (BIOTENE MOISTURIZING MOUTH SPRAY (2013 FORMULATION) OROMUCOSAL SPRAY FOR DRY MOUTH. CO-SUSPECT PRODUCTS INCLUDED SODIUM FLUORIDE (BIOTENE DRY MOUTH FLUORIDE TOOTHPASTE FRESH MINT (2013 FORMULATION)) TOOTHPASTE FOR DRY MOUTH. CONCURRENT MEDICAL CONDITIONS INCLUDED DRY MOUTH (DUE TO SJOGREN'S SYNDROME). CONCOMITANT PRODUCTS INCLUDED GLYCERIN (BIOTENE ORAL BALANCE GEL (2013 FORMULATION)) AND GLYCERIN (BIOTENE MOUTHWASH (2013 FORMULATION)). ON AN UNKNOWN DATE, THE PATIENT STARTED BIOTENE MOISTURIZING MOUTH SPRAY (2013 FORMULATION) AT AN UNKNOWN DOSE AND FREQUENCY AND BIOTENE DRY MOUTH FLUORIDE TOOTHPASTE FRESH MINT (2013 FORMULATION) AT AN UNKNOWN DOSE AND FREQUENCY. ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING BIOTENE MOISTURIZING MOUTH SPRAY (2013 FORMULATION) AND BIOTENE DRY MOUTH FLUORIDE TOOTHPASTE FRESH MINT (2013 FORMULATION), THE PATIENT EXPERIENCED BURN OF TONGUE (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT), BURNED MOUTH (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT), PAIN, ORAL DISCOMFORT AND PRODUCT QUALITY ISSUE. THE ACTION TAKEN WITH BIOTENE MOISTURIZING MOUTH SPRAY (2013 FORMULATION) WAS UNKNOWN. THE ACTION TAKEN WITH BIOTENE DRY MOUTH FLUORIDE TOOTHPASTE FRESH MINT (2013 FORMULATION) WAS UNKNOWN. ON AN UNKNOWN DATE, THE OUTCOME OF THE BURN OF TONGUE, BURNED MOUTH AND PAIN WERE NOT REPORTED AND THE OUTCOME OF THE ORAL DISCOMFORT AND PRODUCT QUALITY ISSUE WERE UNKNOWN. THE REPORTER CONSIDERED THE BURN OF TONGUE AND BURNED MOUTH TO BE RELATED TO BIOTENE MOISTURIZING MOUTH SPRAY (2013 FORMULATION) AND BIOTENE DRY MOUTH FLUORIDE TOOTHPASTE FRESH MINT (2013 FORMULATION). IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE PAIN, ORAL DISCOMFORT AND PRODUCT QUALITY ISSUE TO BE RELATED TO BIOTENE MOISTURIZING MOUTH SPRAY (2013 FORMULATION) AND BIOTENE DRY MOUTH FLUORIDE TOOTHPASTE FRESH MINT (2013 FORMULATION). ADDITIONAL INFORMATION: INITIAL AE REPORT RECEIVED VIA PHONE CALL ON (B)(6) 2017. REPORTER INDICATED THAT HIS WIFE SUFFERS FROM DRY MOUTH DUE TO SJOGREN'S SYNDROME AND HAS USED ALL OF THE BIOTENE PRODUCTS, BUT BIOTENE MOISTURIZING MOUTH SPRAY (2013 FORMULATION) AND BIOTENE DRY MOUTH FLUORIDE TOOTHPASTE FRESH MINT (2013 FORMULATION) HAVE TOO MUCH MINT IN THEM; THEY ARE VERY STRONG. HE REPORTED THAT THE PRODUCTS BURNED HER TONGUE AND MOUTH AND SUGGESTED THAT GSK PUT LESS MINT IN THEM. THE REPORTER AND HIS WIFE HAVE SPOKEN TO OTHER DRY MOUTH SUFFERS WHO HAVE THE SAME PROBLEM. FOLLOW UP EMAIL RECEIVED FROM REPORTER ON (B)(6) 2017. REPORTER INDICATED THAT HIS WIFE SUFFERS A LOT FROM DRY MOUTH AND SHE USES ALL OF THE BIOTENE PRODUCTS. SHE HAS A LOT OF PAIN WHEN SHE USES BIOTENE MOISTURIZING MOUTH SPRAY (2013 FORMULATION) AND BIOTENE DRY MOUTH FLUORIDE TOOTHPASTE FRESH MINT (2013 FORMULATION) BECAUSE THE MINT IS VERY STRONG IN THESE TWO PRODUCTS. HE STATED THAT THE REST OF THE PRODUCTS LIKE BIOTENE ORAL BALANCE GEL (2013 FORMULATION) AND BIOTENE MOUTHWASH (2013 FORMULATION) "ARE SIMPLY GREAT." HE STATED THAT THEY'VE TALKED ABOUT IT WITH SEVERAL PEOPLE WHO ALSO SUFFER FROM DRY MOUTH AND THEY HAVE THE SAME PROBLEM WITH BIOTENE MOISTURIZING MOUTH SPRAY (2013 FORMULATION) AND BIOTENE DRY MOUTH FLUORIDE TOOTHPASTE FRESH MINT (2013 FORMULATION). LINKED TO (B)(4). CORRECTION FOR INFORMATION RECEIVED ON 14-JUN-2017: UPON INTERNAL REVIEW IT WAS DETERMINED EVENT "PRODUCT QUALITY ISSUE" TO BE REMOVED.
BURNED TONGUE. BURNED MOUTH. PAIN. HAVE TOO MUCH MINT IN THEM/THEY ARE VERY STRONG [ORAL DISCOMFORT]. HAVE TOO MUCH MINT IN THEM/THEY ARE VERY STRONG [PRODUCT QUALITY ISSUE]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER VIA CALL CENTER REPRESENTATIVE AND DESCRIBED THE OCCURRENCE OF BURN OF TONGUE IN A FEMALE PATIENT WHO RECEIVED GLYCERIN (BIOTENE MOISTURIZING MOUTH SPRAY (2013 FORMULATION)) OROMUCOSAL SPRAY FOR DRY MOUTH. CO-SUSPECT PRODUCTS INCLUDED SODIUM FLUORIDE (BIOTENE DRY MOUTH FLUORIDE TOOTHPASTE FRESH MINT (2013 FORMULATION)) TOOTHPASTE FOR DRY MOUTH. CONCURRENT MEDICAL CONDITIONS INCLUDED DRY MOUTH (DUE TO SJOGREN'S SYNDROME). CONCOMITANT PRODUCTS INCLUDED GLYCERIN (BIOTENE ORAL BALANCE GEL (2013 FORMULATION)) AND GLYCERIN (BIOTENE MOUTHWASH (2013 FORMULATION)). ON AN UNKNOWN DATE, THE PATIENT STARTED BIOTENE MOISTURIZING MOUTH SPRAY (2013 FORMULATION) AT AN UNKNOWN DOSE AND FREQUENCY AND BIOTENE DRY MOUTH FLUORIDE TOOTHPASTE FRESH MINT (2013 FORMULATION) AT AN UNKNOWN DOSE AND FREQUENCY. ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING BIOTENE MOISTURIZING MOUTH SPRAY (2013 FORMULATION) AND BIOTENE DRY MOUTH FLUORIDE TOOTHPASTE FRESH MINT (2013 FORMULATION), THE PATIENT EXPERIENCED BURN OF TONGUE (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT), BURNED MOUTH (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT), PAIN, ORAL DISCOMFORT AND PRODUCT QUALITY ISSUE. THE ACTION TAKEN WITH BIOTENE MOISTURIZING MOUTH SPRAY (2013 FORMULATION) WAS UNKNOWN. THE ACTION TAKEN WITH BIOTENE DRY MOUTH FLUORIDE TOOTHPASTE FRESH MINT (2013 FORMULATION) WAS UNKNOWN. ON AN UNKNOWN DATE, THE OUTCOME OF THE BURN OF TONGUE, BURNED MOUTH AND PAIN WERE NOT REPORTED AND THE OUTCOME OF THE ORAL DISCOMFORT AND PRODUCT QUALITY ISSUE WERE UNKNOWN. THE REPORTER CONSIDERED THE BURN OF TONGUE AND BURNED MOUTH TO BE RELATED TO BIOTENE MOISTURIZING MOUTH SPRAY (2013 FORMULATION) AND BIOTENE DRY MOUTH FLUORIDE TOOTHPASTE FRESH MINT (2013 FORMULATION). IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE PAIN, ORAL DISCOMFORT AND PRODUCT QUALITY ISSUE TO BE RELATED TO BIOTENE MOISTURIZING MOUTH SPRAY (2013 FORMULATION) AND BIOTENE DRY MOUTH FLUORIDE TOOTHPASTE FRESH MINT (2013 FORMULATION). ADDITIONAL INFORMATION: INITIAL AE REPORT RECEIVED VIA PHONE CALL ON 13-JUN-2017. REPORTER INDICATED THAT HIS WIFE SUFFERS FROM DRY MOUTH DUE TO SJOGREN'S SYNDROME AND HAS USED ALL OF THE BIOTENE PRODUCTS, BUT BIOTENE MOISTURIZING MOUTH SPRAY (2013 FORMULATION) AND BIOTENE DRY MOUTH FLUORIDE TOOTHPASTE FRESH MINT (2013 FORMULATION) HAVE TOO MUCH MINT IN THEM; THEY ARE VERY STRONG. HE REPORTED THAT THE PRODUCTS BURNED HER TONGUE AND MOUTH AND SUGGESTED THAT GSK PUT LESS MINT IN THEM. THE REPORTER AND HIS WIFE HAVE SPOKEN TO OTHER DRY MOUTH SUFFERS WHO HAVE THE SAME PROBLEM. FOLLOW UP EMAIL RECEIVED FROM REPORTER ON 14-JUN-2017. REPORTER INDICATED THAT HIS WIFE SUFFERS A LOT FROM DRY MOUTH AND SHE USES ALL OF THE BIOTENE PRODUCTS. SHE HAS A LOT OF PAIN WHEN SHE USES BIOTENE MOISTURIZING MOUTH SPRAY (2013 FORMULATION) AND BIOTENE DRY MOUTH FLUORIDE TOOTHPASTE FRESH MINT (2013 FORMULATION) BECAUSE THE MINT IS VERY STRONG IN THESE TWO PRODUCTS. HE STATED THAT THE REST OF THE PRODUCTS LIKE BIOTENE ORAL BALANCE GEL (2013 FORMULATION) AND BIOTENE MOUTHWASH (2013 FORMULATION) "ARE SIMPLY GREAT." HE STATED THAT THEY'VE TALKED ABOUT IT WITH SEVERAL PEOPLE WHO ALSO SUFFER FROM DRY MOUTH AND THEY HAVE THE SAME PROBLEM WITH BIOTENE MOISTURIZING MOUTH SPRAY (2013 FORMULATION) AND BIOTENE DRY MOUTH FLUORIDE TOOTHPASTE FRESH MINT (2013 FORMULATION). LINKED TO (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 438707 | BIOTENE MOISTURIZING MOUTH SPRAY (2013 FORMULATION) | ORAL SPRAY | LFD | ULTRADENT PRODUCTS INC./ ORATECH LLC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |