MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-13 for FIXODENT DENTURE ADHESIVE manufactured by Unk.
[91887736]
Who you are: local government agency. A (b)(6) female with report by caretaker of applying "a lot amounts of dental fixative (fixodent) who applied product liberally to her dentures, put dentures in her mouth and minutes later began choking and became unresponsive and death was pronounced upon paramedic arrival at the residence. I performed an autopsy on (b)(6) on (b)(6) 2017 ((b)(4) county coroner (b)(4)) with the cause of death due to asphyxia as a result of airway obstruction by a foreign body. The foreign body was a mass of denture fixative that obstructed her upper airway. Case number:(b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5073235 |
| MDR Report Key | 7024388 |
| Date Received | 2017-11-13 |
| Date of Report | 2017-10-25 |
| Date of Event | 2017-10-24 |
| Date Added to Maude | 2017-11-13 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | FIXODENT DENTURE ADHESIVE |
| Generic Name | FIXODENT DENTURE ADHESIVE |
| Product Code | KOO |
| Date Received | 2017-11-13 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2017-11-13 |