MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-01-30 for BIOTENE ORIGINAL ORAL RINSE (ORIGINAL) manufactured by Kik Custom Products.
[134449782]
Report # 9615332-2019-00009 is associated with (b)(4), biotene original oral rinse (original).
Patient Sequence No: 1, Text Type: N, H10
[134449783]
I couldn't really speak at first when i swallowed it. It was bad [accidental device ingestion]; i was choking [choking]; as time went on i was able to speak more [aphasia]; i was also coughing [cough]; it says on the bottle do not swallow. I didn't mean too. I only swallowed some of what i had in my mouth [intentional device misuse]. Case description: this case was reported by a consumer and described the occurrence of accidental device ingestion in a (b)(6) year-old female patient who received glycerin (biotene original oral rinse (original)) mouth wash (batch number 8k157c, expiry date 30th september 2021) for dry mouth. On an unknown date, the patient started biotene original oral rinse (original). On an unknown date, an unknown time after starting biotene original oral rinse (original), the patient experienced accidental device ingestion (serious criteria gsk medically significant), choking (serious criteria gsk medically significant), aphasia, cough and intentional device misuse. The action taken with biotene original oral rinse (original) was unknown. On an unknown date, the outcome of the accidental device ingestion, choking, aphasia, cough and intentional device misuse were unknown. It was unknown if the reporter considered the accidental device ingestion and intentional device misuse to be related to biotene original oral rinse (original). The reporter considered the choking, aphasia and cough to be related to biotene original oral rinse (original). Additional information: adverse event information was received via call on (b)(6) 2019. The consumer called in about gaviscon and reported that, "so i noticed on the label, it says to chew two to four tablets four times a day. Does this mean at a time or what? When i chew them, they get so big in my mouth that there is not enough room for it. The way they blow up. They are like chalky, so when you chew them, they are hard to do so. I have never taken them before. Do you also handle biotene? Why is when i called in the other day, i got the business from the clerk i spoke to, i swallowed it so i called you guys and i couldn't get anything from her, then she hung up the phone. I couldn't really speak at first when i swallowed it. It was bad, i was choking. As time went on, i was able to speak more. But the feeling wasn't good. It says on the bottle do not swallow. I didn't mean too. I only swallowed some of what i had in my mouth. When you're rinsing your mouth. I was also coughing. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615332-2019-00009 |
| MDR Report Key | 8288260 |
| Report Source | CONSUMER |
| Date Received | 2019-01-30 |
| Date of Report | 2019-01-22 |
| Date Mfgr Received | 2019-01-22 |
| Date Added to Maude | 2019-01-30 |
| 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 | 3 |
| Brand Name | BIOTENE ORIGINAL ORAL RINSE (ORIGINAL) |
| Generic Name | ORAL RINSES |
| Product Code | LFD |
| Date Received | 2019-01-30 |
| Lot Number | 8K157C |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KIK CUSTOM PRODUCTS |
| Manufacturer Address | ETOBICOKE, ONTARIO CA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Other | 2019-01-30 |