MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2019-03-25 for BIOTENE MOISTURIZING MOUTH SPRAY (2013 FORMULATION) manufactured by Ultradent Products Inc/oratech Llc.
[139739692]
This report # is associated with argus case (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[139739693]
Tightness in throat [throat tightness], tingling in throat [pharyngeal paresthesia], choking feeling [choking sensation], having serious issues/side effect slowly come on by the third spray [adverse drug reaction]. This case was reported by a consumer and described the occurrence of throat tightness in a patient who received glycerin (biotene moisturizing mouth spray (2013 formulation)) oromucosal spray for product used for unknown indication. Concurrent medical conditions included sulfonamide allergy. On an unknown date, the patient started biotene moisturizing mouth spray (2013 formulation). On an unknown date, an unknown time after starting biotene moisturizing mouth spray (2013 formulation), the patient experienced throat tightness, tingling throat, choking sensation and drug side effect (serious criteria other: serious per reporter). The action taken with biotene moisturizing mouth spray (2013 formulation) was unknown. On an unknown date, the outcome of the throat tightness, tingling throat, choking sensation and drug side effect were unknown. It was unknown if the reporter considered the throat tightness, tingling throat, choking sensation and drug side effect to be related to biotene moisturizing mouth spray (2013 formulation). Additional details: the consumer advised that absolutely should not be used by anyone with allergy to sulfa drugs as saccharine was a sulfonamide derivative. It can be downright deadly depending on how sensitive of a person. Consumer experienced tightness and tingling in throat and building choking feeling and the side effect slowly came on by the third spray of the day and the consumer was starting to have serious issues.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012293198-2019-00038 |
| MDR Report Key | 8448126 |
| Report Source | CONSUMER,FOREIGN |
| Date Received | 2019-03-25 |
| Date of Report | 2019-03-06 |
| Date Mfgr Received | 2019-05-23 |
| Date Added to Maude | 2019-03-25 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | GLAXOSMITHKLINE RESEARCH TRIANGLE PARK |
| Manufacturer City | PO BOX 13398 NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 8888255249 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIOTENE MOISTURIZING MOUTH SPRAY (2013 FORMULATION) |
| Generic Name | ORAL SPRAY |
| Product Code | LFD |
| Date Received | 2019-03-25 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ULTRADENT PRODUCTS INC/ORATECH LLC |
| Manufacturer Address | SOUTH JORDAN UT US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-03-25 |