MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-03-25 for BIOTENE MOUTH SPRAY (SAVANNAH) manufactured by Ultradent Products Inc/oratech Llc.
[139739140]
This report # is associated with argus case (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[139739141]
This case was reported by a other health professional and described the occurrence of accidental device ingestion in a (b)(6) female patient who received glycerin (biotene mouth spray (savannah)) oromucosal spray (batch number unk, expiry date unknown) for dry mouth. On an unknown date, the patient started biotene mouth spray (savannah). On an unknown date, an unknown time after starting biotene mouth spray (savannah), the patient experienced accidental device ingestion (serious criteria gsk medically significant) and difficulty breathing. The action taken with biotene mouth spray (savannah) was unknown. On an unknown date, the outcome of the accidental device ingestion and difficulty breathing were unknown. It was unknown if the reporter considered the accidental device ingestion and difficulty breathing to be related to biotene mouth spray (savannah). 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 05 march 2019. The consumer reported that, "i have a consumer that accidently ingested the biotene spray and she is saying she is having difficulty breathing now. I gave her benadryl, but i wondered if you had any further recommendations. I will have the consumer call back in to provide you with the information needed. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012293198-2019-00036 |
| MDR Report Key | 8448361 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-03-25 |
| Date of Report | 2019-03-05 |
| Date Mfgr Received | 2019-04-01 |
| Date Added to Maude | 2019-03-25 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | PO BOX 13398 RESEARCH TRIANGLE PARK |
| Manufacturer City | 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 MOUTH SPRAY (SAVANNAH) |
| Generic Name | ORAL SPRAY |
| Product Code | LFD |
| Date Received | 2019-03-25 |
| Lot Number | UNK |
| 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 | 2019-03-25 |