MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-02 for BIOTENE MOUTH SPRAY (ORIGINAL) manufactured by Ultradent Products Inc/oratech Llc.
[131900396]
Report # 3012293198-2018-00015 is associated with (b)(4), biotene mouth spray.
Patient Sequence No: 1, Text Type: N, H10
[131900397]
It caused me hospitalization [hospitalization]; my throat was on fire and closed down [burning in throat]; my throat was on fire and closed down. [throat constriction]; i just had an immediate violent reaction with it. [adverse drug reaction]. Case description: this case was reported by a consumer and described the occurrence of hospitalization in a (b)(6) year-old male patient who received glycerin (biotene mouth spray (original)) oromucosal spray (batch number ush101, expiry date 31st july 2020) for dry mouth. On (b)(6) 2018, the patient started biotene mouth spray (original) at an unknown dose and frequency. On an unknown date, an unknown time after starting biotene mouth spray (original), the patient experienced hospitalization (serious criteria gsk medically significant), burning in throat, throat constriction and adverse drug reaction. The patient was treated with oxybutynin. Biotene mouth spray (original) was discontinued on (b)(6) 2018 (dechallenge was positive). On an unknown date, the outcome of the hospitalization, burning in throat, throat constriction and adverse drug reaction were recovering/resolving. The reporter considered the hospitalization to be related to biotene mouth spray (original). It was unknown if the reporter considered the burning in throat, throat constriction and adverse drug reaction to be related to biotene mouth spray (original). Additional information: adverse event information was received on 18 december 2018. Consumer reported that, "i have used your product before and recently i got biotene spray the mint flavor 1. 5oz, it caused me hospitalization. My throat was on fire and closed down. I was given oxybutynin. I have used the spray 2 days ago but only used it for one day. My condition has improved and yes could call the physician that checked me. I got the spray, it has a lot id ush101 and expiry date july 2020. I just had an immediate violent reaction with it. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012293198-2018-00015 |
| MDR Report Key | 8208806 |
| Date Received | 2019-01-02 |
| Date of Report | 2018-12-19 |
| Date Mfgr Received | 2019-01-11 |
| Date Added to Maude | 2019-01-02 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BIOTENE MOUTH SPRAY (ORIGINAL) |
| Generic Name | ORAL SPRAY |
| Product Code | LFD |
| Date Received | 2019-01-02 |
| Lot Number | U8H101 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Age | DA |
| 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. Hospitalization; 2. Other | 2019-01-02 |