MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-09-21 for FIXODENT DENTURE ADHESIVE, VERSION UNKNOWN manufactured by Proctor & Gamble Manufacturing Co..
[87204317]
Return of product has been requested. 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
[87204318]
Dyes in the (fixodent) product set off an allergic reaction [allergic reaction to excipient], unable to breathe [dyspnoea], throat is closing; swelling throat [pharyngeal oedema], swollen lips [lip swelling], swollen tongue [swollen tongue], swelling to gum [gingival swelling], can't use anything with any dye in it, allergies include dyes [documented hypersensitivity to administered product]. Case description: a female consumer, age unspecified, reported spontaneously via phone on (b)(6) 2017 that she used fixodent denture adhesive, version unknown cream, also referred to as fixodent plus, 1 application, 1 only for the first time, and she was swelling up; her throat was closing, lips were swollen, and her tongue was swollen beginning (b)(6) 2017. Treatment details were unknown. The case outcome was not recovered/not resolved. Relevant history: none reported. Concomitant product(s): none reported. No further information was provided. On 06-sep-2017 consumer relations department consumer follow-up phone call: according to the (b)(6) consumer, she was having a procedure completed at the dentist when while there they put the fixodent product that she believed was fixodent plus in her mouth with her dentures. She did not know that they were putting the product in her mouth as she clarified that she did not normally use those kind of things and she was afraid that the product contained some kind of numbing agents. The consumer's allergies included novocaine and caines, all medications that have caine at the end, dyes, eggs, dairy, and chicken. The consumer asserted that most medications contain dye and, at the time of her exposure to the fixodent, she was panicked because she could not use anything with any kind of dye in it and the dye in the fixodent product set off an allergic reaction. The experience consisted of swelling to her gum, tongue, throat, and she was unable to breathe. The reaction occurred within seconds of fitting her dentures and they had to stop. Prior to visiting an emergency room, she had taken two epi-pens as she was panicking. Once seen by the emergency room doctor, treatment included epinephrine injection, benadryl injection, and an antacid which she believed was pepcid given to her orally. According to the consumer, she was discharged from the emergency room and an overnight stay in the hospital was not necessary. However, she was told to continue taking liquid dye-free benadryl. At the present time, her symptoms had recovered. The consumer indicated that she had been looking around for denture creams without dyes but she could not locate any for her use. The case outcome was recovered. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1530449-2017-00006 |
| MDR Report Key | 6882690 |
| Report Source | CONSUMER |
| Date Received | 2017-09-21 |
| Date of Report | 2017-08-30 |
| Date of Event | 2017-08-30 |
| Date Mfgr Received | 2017-09-06 |
| Date Added to Maude | 2017-09-21 |
| 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, VERSION UNKNOWN |
| Generic Name | ADHESIVE, DENTURE |
| Product Code | KOO |
| Date Received | 2017-09-21 |
| Lot Number | NOT AVAILABLE |
| ID Number | NOT AVAILABLE |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PROCTOR & GAMBLE MANUFACTURING CO. |
| Manufacturer Address | BROWN SUMMIT NC US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-09-21 |