MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-10 for BIOTENE ORAL RINSE (UNSPECIFIED VARIANT) manufactured by Kik Custom Products.
[129878688]
9615332-2018-00172 is associated with argus case (b)(4), biotene oral rinse (unspecified variant).
Patient Sequence No: 1, Text Type: N, H10
[129878809]
I ended up in the hospital with a severe potassium deficiency [potassium deficiency]. Case description: this case was reported by a consumer via interactive digital media and described the occurrence of potassium deficiency in a patient who received glycerin (biotene oral rinse (unspecified variant)) mouth wash (batch number unk, expiry date unknown) for dry mouth. 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 potassium deficiency (serious criteria hospitalization and gsk medically significant). Biotene oral rinse (unspecified variant) was discontinued (dechallenge was unknown). On an unknown date, the outcome of the potassium deficiency was unknown. The reporter considered the potassium deficiency to be related to biotene oral rinse (unspecified variant). This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details, adverse event information was received on (b)(6) 2018 via facebook. Consume posted that "i used this for over 3 weeks when my mouth was so dry. It worked temporarily, but i ended up in the hospital with a severe potassium deficiency. Please everyone try to find the cause of your dry mouth before masking it".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615332-2018-00172 |
| MDR Report Key | 8148786 |
| Date Received | 2018-12-10 |
| Date of Report | 2018-11-11 |
| Date Mfgr Received | 2018-11-11 |
| Date Added to Maude | 2018-12-10 |
| 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 | 2018-12-10 |
| 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. Hospitalization; 2. Other | 2018-12-10 |