MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-05-03 for BIOTENE MOUTH SPRAY (ORIGINAL) manufactured by Ultradent Products Inc/oratech Llc.
[144099168]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[144099169]
Started choking [choking]; i swallowed the biotene moisturizing mouth spray [accidental device ingestion]; i have a cough [cough]; i had difficulty breathing [difficulty breathing]; i had mucus in my throat [throat secretion increased]. 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 u8h011, expiry date 30th june 2020) for dry mouth. Concomitant products included paracetamol (tylenol). In (b)(6) 2019, the patient started biotene mouth spray (original). On (b)(6) 2019, an unknown time after starting biotene mouth spray (original), the patient experienced choking (serious criteria gsk medically significant), cough, difficulty breathing and throat secretion increased. On (b)(6) 2019, the patient experienced accidental device ingestion (serious criteria gsk medically significant). The action taken with biotene mouth spray (original) was unknown. On an unknown date, the outcome of the choking, accidental device ingestion, cough, difficulty breathing and throat secretion increased were unknown. It was unknown if the reporter considered the choking, accidental device ingestion, cough, difficulty breathing and throat secretion increased to be related to biotene mouth spray (original). Additional information: adverse event information was received via live call on (b)(6) 2019. The consumer stated, i swallowed the biotene moisturizing mouth spray. I swished it around and swallowed it and started choking. I had mucus in my throat. I have a cough. Is this normal? I drank warm water and tried to gargle with salt water. I also took cough drops. I tried to take my blood medications and medication for my eye. I took tylenol and other medications. I had difficulty breathing. This just started today. I will not be seeking medical advice. I will call you back if i go to the doctor. I had difficulty breathing. I was choking and coughing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012293198-2019-00067 |
| MDR Report Key | 8579062 |
| Report Source | CONSUMER |
| Date Received | 2019-05-03 |
| Date of Report | 2019-04-15 |
| Date of Event | 2019-04-14 |
| Date Mfgr Received | 2019-04-15 |
| Date Added to Maude | 2019-05-03 |
| 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 (ORIGINAL) |
| Generic Name | ORAL SPRAY |
| Product Code | LFD |
| Date Received | 2019-05-03 |
| 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 | 2019-05-03 |