MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-26 for BIOTENE MOUTH SPRAY (ORIGINAL) manufactured by Ultradent Products Inc/oratech Llc.
[128569220]
Mfr report is associated with argus case (b)(4), biotene mouth spray (original).
Patient Sequence No: 1, Text Type: N, H10
[128569221]
Went directly on his throat and its choking him [choking], i am calling to report that my husband accidentally swallowed the biotene spray liquid [accidental device ingestion], expiration date is 31 "jully" 2018 [expired device used]. Case description: this case was reported by a consumer and described the occurrence of choking in a male patient who received glycerin (biotene mouth spray (original)) oromucosal spray (batch number u6j221, expiry date 31st july 2018) for product used for unknown indication. On an unknown date, the patient started biotene mouth spray (original). On an unknown date, an unknown time after starting biotene mouth spray (original), the patient experienced choking (serious criteria gsk medically significant), accidental device ingestion (serious criteria gsk medically significant) and expired device used. The action taken with biotene mouth spray (original) was unknown. On an unknown date, the outcome of the choking, accidental device ingestion and expired device used were unknown. The reporter considered the choking and accidental device ingestion to be related to biotene mouth spray (original). It was unknown if the reporter considered the expired device used to be related to biotene mouth spray (original). Additional information: adverse event information was received on 20 november 2018. Consumer stated, "i am calling to report that my husband accidentally swallowed the biotene spray, when he sprayed it, it went directly on his throat and 'its' choking him really bad. I want to know what in the product "that" might be bad for him".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012293198-2018-00014 |
| MDR Report Key | 8103192 |
| Date Received | 2018-11-26 |
| Date of Report | 2018-11-20 |
| Date Mfgr Received | 2018-11-20 |
| Date Added to Maude | 2018-11-26 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| 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 MOUTH SPRAY (ORIGINAL) |
| Generic Name | ORAL SPRAY |
| Product Code | LFD |
| Date Received | 2018-11-26 |
| Lot Number | U6J221 |
| Device Expiration Date | 2018-07-31 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ULTRADENT PRODUCTS INC/ORATECH LLC |
| Manufacturer Address | SOUTH JORDAN UT US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-11-26 |