MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-02-15 for BIOTENE ORIGINAL ORAL RINSE (ORIGINAL) manufactured by Kik Custom Products.
[136259739]
Mfr report is associated with argus case (b)(4), biotene original oral rinse (original).
Patient Sequence No: 1, Text Type: N, H10
[136259740]
I accidentally "the" swallowed a bit of biotene [accidental device ingestion]. I choked [choking]. It burned my inner mouth [burning mouth]. I continued the cough [coughing]. It kind of upset my stomach [upset stomach]. Case description: this case was reported by a consumer and described the occurrence of accidental device ingestion in a (b)(6) female patient who received glycerin (biotene original oral rinse (original)) mouth wash (batch number unknown, expiry date unknown) 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), burning mouth, coughing and upset stomach. The action taken with biotene original oral rinse (original) was unknown. On an unknown date, the outcome of the accidental device ingestion, choking, burning mouth, coughing and upset stomach were unknown. The reporter considered the accidental device ingestion, choking, burning mouth, coughing and upset stomach to be related to biotene original oral rinse (original). Additional information: adverse event information was received on 13 february 2019 via live call. Consumer reported that, "i accidentally the swallow a bit of biotene and it burn my inner mouth and kind upset my stomach i continued the cough and i choked and try several thing like warm water and cold water. According to the product label some ingredients may harm you or poisonous? ".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012293198-2019-00012 |
| MDR Report Key | 8343006 |
| Report Source | CONSUMER |
| Date Received | 2019-02-15 |
| Date of Report | 2019-02-13 |
| Date Mfgr Received | 2019-02-13 |
| Date Added to Maude | 2019-02-15 |
| 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 ORIGINAL ORAL RINSE (ORIGINAL) |
| Generic Name | ORAL RINSES |
| Product Code | LFD |
| Date Received | 2019-02-15 |
| 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 | 2019-02-15 |