MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2016-04-13 for FIXODENT DENTURE ADHESIVE COMPLETE manufactured by Procter & Gamble Manufacturing Co..
[42516942]
Product and lot number not provided by reporter, therefore unable to proceed with product investigation at this time. Full evaluation will occur upon receipt of returned product.
Patient Sequence No: 1, Text Type: N, H10
[42516943]
Couldn't breathe [dyspnoea] pain-throat [oropharyngeal pain] during swallow exercises inhaled a piece of fixodent [accidental exposure to product] inhaled a piece of fixodent [exposure via inhalation]. Case description: a consumer, age and gender unspecified, reported being a recent tonsil cancer patient who had to have a flap and a fistula and spend 11 days in the hospital. The consumer described how upon discharge from the hospital he/she started swallow therapy and during his/her swallow exercise inhaled a piece of the fixodent denture adhesive complete. The consumer stated that he/she could not breathe and had to go to the hospital to have it suctioned out. The consumer reported having pain from the experience as well, given that he/she had undergone a month and a half of throat surgery. The consumer stated that he/she had used the fixodent original in the past and that it seemed to always work the best, however, the problem is that the hole is too large, and questioned why the fixodent original could not have the same thin top as the others, which work so well. The consumer stated that he/she does not use much of the product, just the bare minimum that will hold his/her teeth in. The case outcome was recovered. No further information was provided. On (b)(6) 2016 consumer follow-up email: the consumer expressed that a thin tube nozzle on the fixodent denture adhesive complete would mean a lot to her and she believes that many people, especially the elderly, would benefit from it. She stated that she was feeling better and that it took about 1/2 hour for her ent (ear, nose & throat specialist) to suction the fixodent out. She described that it probably would not have been so bad but she had just had a flap put in and also a neck dissection. She reported that they are saying that it looks like her cancer is gone and she will know more with the next ct (computerized tomography)/pet (positron emission tomography) scan, but it is the cancer side effects that are horrible. The case outcome remained recovered. No further information was provided. On (b)(6) 2016 consumer follow-up: the consumer, a (b)(6) female, reported that she is doing well now and her cancer is gone. She stated that her main reason for writing in the first place was to recommend that the company change the nozzle size on the fixodent denture adhesive complete. She recounted how her experience occurred on (b)(6) 2016 when she was applying fixodent to her dentures and a small piece of the glue came off and she inhaled it. She described how she had some shortness of breath and pain in her throat so she went to her doctor a couple of days later. She reported that the doctor suctioned her throat and got it out, that her shortness of breath went away immediately, but the pain lasted a few days. She stated that she did not spend any time in the hospital. She described how she only applies a small dot of fixodent on her bottom plate and 2 dots on her upper denture once a day. Relevant history: drug allergy-clindamycin, vancomycin; medical history-asthma. The case outcome remained recovered. No further information was provided. On (b)(6) 2016 consumer follow-up: the consumer reported that she just wanted to see if the company could do something about changing the nozzle size on the fixodent denture adhesive complete. She stated that she was recovering from tonsil cancer and has a lot going on right now as far as rehabilitation, swallow therapy and doctor appointments related to that. She reported that she thought her suggestion might give some thought to making this a better product. The case outcome remained recovered. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1530449-2016-00003 |
| MDR Report Key | 5573093 |
| Report Source | CONSUMER |
| Date Received | 2016-04-13 |
| Date of Report | 2016-03-15 |
| Date of Event | 2016-03-09 |
| Date Mfgr Received | 2016-03-15 |
| Date Added to Maude | 2016-04-13 |
| 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 Street | 8700 MASON MONTGOMERY ROAD |
| Manufacturer City | MASON OH 45040 |
| Manufacturer Country | US |
| Manufacturer Postal | 45040 |
| 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 | FIXODENT DENTURE ADHESIVE COMPLETE |
| Generic Name | ADHESIVE, DENTURE |
| Product Code | KOO |
| Date Received | 2016-04-13 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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. Other | 2016-04-13 |