MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-03-22 for BIOTENE MOUTH SPRAY (SAVANNAH) manufactured by Ultradent Products Inc/oratech Llc.
[139571288]
The report # 3012293198-2019-00027 is associated with (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[139571289]
I used it last night. Some must've gotten down left side traquea [accidental device ingestion]. I was beet red in the face [red face]. Coughed a lot / happens when you cough a lot [cough]. I had difficulty breathing / i could hardly get air in [difficulty breathing]. Swallowing discomfort [discomfort]. I threw up last night [vomiting]. Some must've gotten down left side traquea. It is irritated [respiratory tract irritation]. Today i can still feel it, trouble talking, difficulty [oral discomfort]. I had an adverse reaction / it doesn't say anything about this occurring. This significant reaction [adverse drug reaction] i probably didn't do it right [wrong technique in device usage process]. Case description: this case was reported by a consumer and described the occurrence of fear in a (b)(6) year-old female patient who received glycerin (biotene mouth spray (savannah)) oromucosal spray (batch number usj021, expiry date 31st july 2019) for dry mouth. On an unknown date, the patient started biotene mouth spray (savannah). On (b)(6) 2019, less than an hour after starting biotene mouth spray (savannah), the patient experienced fear, red face, cough, difficulty breathing, panic reaction, discomfort, vomiting, respiratory tract irritation, speech disorder and emotional distress. On an unknown date, the patient experienced adverse drug reaction and wrong technique in device usage process. Biotene mouth spray (savannah) was discontinued on (b)(6) 2019. On an unknown date, the outcome of the fear, red face, cough, difficulty breathing, panic reaction, discomfort, vomiting, respiratory tract irritation, speech disorder, emotional distress, adverse drug reaction and wrong technique in device usage process were unknown. The reporter considered the fear, red face, cough, difficulty breathing, panic reaction, discomfort, vomiting, respiratory tract irritation, speech disorder, emotional distress and adverse drug reaction to be related to biotene mouth spray (savannah). It was unknown if the reporter considered the wrong technique in device usage process to be related to biotene mouth spray (savannah). Additional information: adverse event information was received on (b)(6) 2019 via live call. Consumer reported that, "well my sister gave you your product the biotene spray because i have dry mouth and i used it last night. Some must've gotten down left side traquea. It is irritated, i had difficulty breathing and coughed a lot. I'm a nurse was a little panic, it lasted probably 30 minutes to 1 hr. I could hardly get air in and coughed a lot i beet red in the face. I was afraid i was going to have to go to the hospital. I probably didn't do it right. I'm calling because i am throwing this out, i'm upset with the reaction i had. I had an adverse reaction. Today i can still feel it, trouble talking, difficulty. I threw up last night sometimes happens when you cough a lot. I don't have the package. It doesn't say anything about this occurring this significant reaction. I can still feel it today swallowing. Do you recommend i do? I used it once while i was down there and this is the second time i used it. I would like to have a call back about that. Any side effect when they put it on the label. Someone could have a reaction. I think it should be put on the label. I want to know what was the result of this. Do many dentist give this out to patients? ".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012293198-2019-00027 |
| MDR Report Key | 8443633 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-03-22 |
| Date of Report | 2019-02-22 |
| Date Mfgr Received | 2019-05-13 |
| Date Added to Maude | 2019-03-22 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | PO BOX 13398 |
| Manufacturer City | RESEARCH TRIANGLE PARK 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 MOUTH SPRAY (SAVANNAH) |
| Generic Name | ORAL SPRAY |
| Product Code | LFD |
| Date Received | 2019-03-22 |
| Lot Number | USJ021 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2019-03-22 |