MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-04-29 for BIOTENE MOUTH SPRAY (UNKNOWN) manufactured by Ultradent Products Inc/oratech Llc.
[143392627]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[143392628]
I accidentally sprayed too far back in my throat [accidental device ingestion]. I had a hard time falling asleep [sleepiness]. I accidentally sprayed too far back in my throat, and i immediately felt a horrible burning sensation. [throat burning sensation of]. I coughed so hard that i vomited. [cough]. I coughed so hard that i vomited. [vomiting]. It hurt when i breathed [difficulty breathing]. It hurt when i breathed, and i couldn't get rid of the pain. [oral pain]. I looked at my throat in the mirror and it was bright red. [red throat]. This case was reported by a consumer via interactive digital media and described the occurrence of accidental device ingestion in a female patient who received glycerin (biotene mouth spray (unknown)) oromucosal spray (batch number unk, expiry date unknown) for product used for unknown indication. On an unknown date, the patient started biotene mouth spray (unknown) at an unknown dose and frequency. On an unknown date, an unknown time after starting biotene mouth spray (unknown), the patient experienced accidental device ingestion (serious criteria gsk medically significant), sleepiness, throat burning sensation of, cough, vomiting, difficulty breathing, oral pain and red throat. The action taken with biotene mouth spray (unknown) was unknown. On an unknown date, the outcome of the accidental device ingestion was unknown and the outcome of the sleepiness, throat burning sensation of, cough, vomiting, difficulty breathing, oral pain and red throat were recovering/ resolving. It was unknown if the reporter considered the accidental device ingestion to be related to biotene mouth spray (unknown). The reporter considered the sleepiness, throat burning sensation of, cough, vomiting, difficulty breathing, oral pain and red throat to be related to biotene mouth spray (unknown). Additional information, adverse event information was received on 02 april 2019 via interactive digital media ((b)(6)). The consumer posted" hi. I accidentally sprayed my throat and it feels like it was chemically burned. How do i make it go away? " follow-up adverse event information was received on 03 april 2019 vie email. The consumer stated "hi i sent a message on (b)(6) about what happened when used the biotene spray yesterday. I accidentally sprayed too far back in my throat, and i immediately felt a horrible burning sensation. It made me cough, and i coughed so hard that i vomited. It hurt when i breathed, and i couldn't get rid of the pain. I ended up drinking a lot of ice water and sucked on cough drops, but really the only thing that made it feel better was when i coughed. I missed out on some activities in the afternoon and started to lose my voice because of the coughing. I looked at my throat in the mirror and it was bright red. I had a hard time falling asleep, but today i feel a lot better. It still hurts, but not as much. I really like this product because i have horrible dry mouth and nothing else has helped, but i'm a little afraid to use it again. " initial and follow up case was processed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012293198-2019-00056 |
| MDR Report Key | 8560141 |
| Report Source | CONSUMER |
| Date Received | 2019-04-29 |
| Date of Report | 2019-04-02 |
| Date Mfgr Received | 2019-04-02 |
| Date Added to Maude | 2019-04-29 |
| 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 (UNKNOWN) |
| Generic Name | ORAL SPRAY |
| Product Code | LFD |
| Date Received | 2019-04-29 |
| Lot Number | UNKNOWN |
| 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 | 2019-04-29 |