MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-02-28 for FIXODENTDENTURECAREDENTUREADHESIVECOMPL manufactured by Procter & Gamble Manufacturing Co..
[101118033]
Lot number or product was not provided by the reporter and case concerns long-term product use.
Patient Sequence No: 1, Text Type: N, H10
[101118034]
Choking, mouth/throat [choking], dizziness [dizziness], tiredness [fatigue], fixodent did not hold (causing him not to be able to chew thoroughly and choking on steak), dentures dislodged [device ineffective]. Case description: an elderly male consumer, age unspecified, provided a spontaneous report via phone on (b)(6) 2018 that he used fixodent denture care denture adhesive complete beginning on an unknown date and tonight it did not hold, causing him not be able to chew his steak thoroughly, which led to him choke on the steak and his dentures to come dislodged. He stated that his wife patted him on the back and then helped him remove the dentures, but that no medical advice/treatment was sought. He reported that he was currently dizzy and tired from the experience. He stated that he had a problem with the product not holding a few days ago also. Relevant history: medical history-denture wearer. Concomitant product(s): none reported. The case outcome was improved. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1530449-2018-00001 |
| MDR Report Key | 7302151 |
| Report Source | CONSUMER |
| Date Received | 2018-02-28 |
| Date of Report | 2018-01-30 |
| Date of Event | 2018-01-30 |
| Date Mfgr Received | 2018-01-30 |
| Date Added to Maude | 2018-02-28 |
| 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 Contact | MGR. REGULATORY ORAL CARE |
| Manufacturer G1 | PROCTER & GAMBLE MANUFACTURING CO. |
| Manufacturer Street | 6200 BRYAN PARK ROAD |
| Manufacturer City | BROWN SUMMIT NC 27214 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27214 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FIXODENTDENTURECAREDENTUREADHESIVECOMPL |
| Generic Name | ADHESIVE, DENTURE |
| Product Code | KOO |
| Date Received | 2018-02-28 |
| Lot Number | NOT AVAILABLE |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PROCTER & GAMBLE MANUFACTURING CO. |
| Manufacturer Address | 6200 BRYAN PARK ROAD BROWN SUMMIT NC 27214 US 27214 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-02-28 |