MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2015-06-19 for FIXODENT DENTURE CARE DENTURE ADHESIVE CONTROL PLUS SCOPEFLAVORCREAMSCOPE FLAVOR manufactured by Procter & Gamble Manufacturing Co..
[18781392]
Hard to breathe [dyspnoea]. Allergic reaction [hypersensitivity]. Starting to go into anaphylaxis [anaphylactic reaction]. Lips are blue [cyanosis]. Whole face is swollen [swelling face]. Swelling-mouth [mouth swelling]. Swelling-throat [pharyngeal oedema]. Throat started closing up [throat tightness]. Eyes were runny and watering [lacrimation increased]. Nasal passage swelling [nasal congestion]. Case description: a female consumer, age unspecified, used fixodent plus scope denture adhesive food seal cream fresh, as she just got her dentures a month ago and her dentures were just starting to slip, and she requested a product ingredient list because she thought she was having an allergic reaction. She explained that she is new to the denture experience and used a little bit of the product for the first time yesterday, (b)(6) 2015. When she awoke today, (b)(6) 2015, and after applying a large amount of the fixodent, her whole face from her nasal passages, mouth, and throat were swollen, her throat was starting to close, her lips were blue, and she was having a hard time breathing. Yesterday, her eyes were runny and watering which she initially attributed to her allergies but now she believed she was starting to go in to anaphylaxis and required her epi-pen. The consumer refused to be transferred to a medical professional; she was planning to take her epi-pen and call back to the company at a later time. The case outcome was not recovered/not resolved. Relevant history: allergies: allergic to quite a few things; medical history: new denture wearer as of a month ago, (b)(6) 2015. Concomitant products were unknown. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5
[19139481]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1530449-2015-00004 |
| MDR Report Key | 4855322 |
| Report Source | 04 |
| Date Received | 2015-06-19 |
| Date of Report | 2015-05-22 |
| Date of Event | 2015-05-22 |
| Date Mfgr Received | 2015-05-22 |
| Date Added to Maude | 2015-06-19 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MGR. REGULATORY ORAL CARE |
| Manufacturer Street | 8700 MASON MONTGOMERY ROAD |
| Manufacturer City | MASON OH 45040 |
| Manufacturer Country | US |
| Manufacturer Postal | 45040 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FIXODENT DENTURE CARE DENTURE ADHESIVE CONTROL PLUS SCOPEFLAVORCREAMSCOPE FLAVOR |
| Generic Name | DENTURE ADHESIVE |
| Product Code | KOO |
| Date Received | 2015-06-19 |
| 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 | BROWN SUMMIT NC US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-06-19 |