MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-12-20 for BIOTENE ORIGINAL ORAL RINSE (ORIGINAL) manufactured by Kik Custom Products.
[130988636]
9615332-2018-00187 is associated with argus case (b)(6), biotene original oral rinse (original).
Patient Sequence No: 1, Text Type: N, H10
[130988637]
I drank a little bit. [accidental device ingestion]. It says do not use if shrink sleeve is missing or broken. What does that mean? It's missing. I drank a little bit [device use error]. 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 8h133c, expiry date 13th july 2021) for dry mouth. On (b)(6) 2018, 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) and device use error. The action taken with biotene original oral rinse (original) was unknown. On an unknown date, the outcome of the accidental device ingestion and device use error were unknown. It was unknown if the reporter considered the accidental device ingestion and device use error to be related to biotene original oral rinse (original). This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences. Additional information, adverse event information was received via call on (b)(6) 2018. The consumer reported that "i just picked a bottle of biotene for the first time and it says do not use if shrink sleeve is missing or broken. What does that mean? It's missing. I drank a little bit. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615332-2018-00187 |
| MDR Report Key | 8184074 |
| Report Source | CONSUMER |
| Date Received | 2018-12-20 |
| Date of Report | 2018-12-18 |
| Date Mfgr Received | 2018-12-18 |
| Date Added to Maude | 2018-12-20 |
| 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 | 2018-12-20 |
| Lot Number | 8H133C |
| 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 | 2018-12-20 |