MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-04-16 for BIOTENE ORIGINAL ORAL RINSE (SAVANNAH) manufactured by Kik Custom Products.
[142210434]
Argus case (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[142210435]
I have sleep apnea. I cant event talk, my lips are like glued together [oral discomfort]. I'm extremely tired, it makes me loopy. I don't think the cough is coming for the biotene rinse. Case description: this case was reported by a consumer and described the occurrence of sleep apnea in a (b)(6) female patient who received glycerin (biotene original oral rinse (savannah)) mouth wash (batch number 9a002c, expiry date 16th december 2021) for product used for unknown indication. On an unknown date, the patient started biotene original oral rinse (savannah). On an unknown date, an unknown time after starting biotene original oral rinse (savannah), the patient experienced sleep apnea (serious criteria gsk medically significant), oral discomfort, tiredness and cough. The action taken with biotene original oral rinse (savannah) was unknown. On an unknown date, the outcome of the sleep apnea, oral discomfort, tiredness and cough were unknown. It was unknown if the reporter considered the sleep apnea, oral discomfort, tiredness and cough to be related to biotene original oral rinse (savannah). Additional information: adverse event information was received via live call on 01 april 2019. The consumer stated, i'm calling about the biotene rinse. I cant event talk, my lips are like glued together. I'm extremely tired. I have used this before and this didn't happen i didn't have the tiredness i think i have sleep apnea. It taste well , it makes me loopy. If mixing with pill maybe if i stop taken them and the other pill. I had doctor that told me i have sleep apnea. Have you ever heard of this? I was used a different product, the was to whitening and the doctor told me to use this. I don't think the cough is coming for the biotene rinse. What product do you have for the biotene. How long have you has this biotene rinse? Where are you located? Was there a change in the formula? Do you have any other flavors.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012293198-2019-00053 |
| MDR Report Key | 8518589 |
| Report Source | CONSUMER |
| Date Received | 2019-04-16 |
| Date of Report | 2019-04-01 |
| Date Mfgr Received | 2019-04-01 |
| Date Added to Maude | 2019-04-16 |
| 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 ORIGINAL ORAL RINSE (SAVANNAH) |
| Generic Name | ORAL RINSES |
| Product Code | LFD |
| Date Received | 2019-04-16 |
| Lot Number | 9A002C |
| 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. Other | 2019-04-16 |