MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-05-08 for BIOTENE MOUTH SPRAY (ORIGINAL) manufactured by Ultradent Products Inc/oratech Llc.
[144403912]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[144403913]
I could not stop choking [choking]. My face was red [red face]. I was scared [fear]. Case description: this case was reported by a consumer and described the occurrence of choking in a (b)(6)-year-old female patient who received glycerin (biotene mouth spray (original)) oromucosal spray (batch number u8h101, expiry date unknown) for dry mouth. On an unknown date, the patient started biotene mouth spray (original). In (b)(6) 2019, an unknown time after starting biotene mouth spray (original), the patient experienced choking (serious criteria gsk medically significant), red face and fear. Biotene mouth spray (original) was discontinued in (b)(6) 2019 (dechallenge was positive). In (b)(6) 2019, the outcome of the choking, red face and fear were recovered/resolved. It was unknown if the reporter considered the choking, red face and fear to be related to biotene mouth spray (original). Additional information: adverse event information was received via call on (b)(6) 2019. The consumer reported that, "i had an appointment with a doctor and while on the way, i could not stop choking. I was scared. And my mouth was dry and my face was red. Drug start date a couple of months ago, stop date 2 months ago and adverse event stopped date that same date and drug used for dry mouth. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012293198-2019-00072 |
| MDR Report Key | 8590574 |
| Report Source | CONSUMER |
| Date Received | 2019-05-08 |
| Date of Report | 2019-04-19 |
| Date Mfgr Received | 2019-04-19 |
| Date Added to Maude | 2019-05-08 |
| 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 RESEARCH TRIANGLE PARK |
| Manufacturer City | 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 (ORIGINAL) |
| Generic Name | ORAL SPRAY |
| Product Code | LFD |
| Date Received | 2019-05-08 |
| Lot Number | U8H101 |
| 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 | 2019-05-08 |