MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-04 for BIOTENE ORAL RINSE (UNSPECIFIED VARIANT) manufactured by Kik Custom Products.
[132203197]
Mfr report is associated with argus case (b)(4), biotene oral rinse (unspecified variant).
Patient Sequence No: 1, Text Type: N, H10
[132203198]
My husband had a stroke and instead of spitting the biotene out he is swallowing it [accidental device ingestion]. Case description: this case was reported by a nurse and described the occurrence of accidental device ingestion in a male patient who received glycerin (biotene oral rinse (unspecified variant)) mouth wash (batch number unk, expiry date unknown) for dry mouth. The patient's past medical history included stroke. On an unknown date, the patient started biotene oral rinse (unspecified variant). On an unknown date, an unknown time after starting biotene oral rinse (unspecified variant), the patient experienced accidental device ingestion (serious criteria gsk medically significant). On an unknown date, the outcome of the accidental device ingestion was unknown. It was unknown if the reporter considered the accidental device ingestion to be related to biotene oral rinse (unspecified variant). Additional information: adverse event information was received via call on 31 december 2018. The consumer reported that, "i am a nurse and my husband had a stroke and instead of spitting the biotene out he is swallowing it. What symptoms should i expect? I read the ingredients on it already. It's a good product and we don't have an issue with it, i appreciate it. I don't want to answer any questions about the experience; i just want to know what the possible side effects would be if this did happen. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615332-2019-00004 |
| MDR Report Key | 8218643 |
| Date Received | 2019-01-04 |
| Date of Report | 2018-12-31 |
| Date Mfgr Received | 2018-12-31 |
| Date Added to Maude | 2019-01-04 |
| 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 | 0 |
| Brand Name | BIOTENE ORAL RINSE (UNSPECIFIED VARIANT) |
| Generic Name | ORAL RINSES |
| Product Code | LFD |
| Date Received | 2019-01-04 |
| Lot Number | UNKNOWN |
| 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 | 2019-01-04 |