MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2015-10-13 for FIXODENT DENTURE CARE DENTURE ADHESIVE COMPLETE CREME manufactured by Procter & Gamble Manufacturing Co..
[28076727]
Product was not provided by the reporter.
Patient Sequence No: 1, Text Type: N, H10
[28076728]
Allergic reaction [hypersensitivity]. Lips swollen [lip swelling]. Hives on thighs, under both arms, spread to feet [urticaria]. Case description: an adult male consumer, age unspecified, used fixodent denture adhesive complete cream for the first time 1 only on (b)(6) 2015 and reported the following: allergic reaction, swelling lips, hives on thighs, under both arms and spreading to his feet all symptoms beginning on (b)(6) 2015. The consumer reported he telephoned a health care professional at the (b)(6) hospital who recommended he visit the emergency room but the consumer refused to go. The consumer stated he was not having trouble breathing and he discontinued use of the product. Treatment included ibuprofen. The case outcome was not recovered / not resolved. Relevant history: none reported. Concomitant products: none reported. No further information was provided. On (b)(6) 2015 (b)(6) follow-up phone call: the consumer visited the emergency department on the evening of (b)(6) 2015 after taking several benadryl and no relief of symptoms. The consumer reported by 5pm the hives had spread to his feet. Treatment in the emergency room included an injection of epinephrine and he was given 2 unspecified oral prescriptions to take for one week. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1530449-2015-00011 |
| MDR Report Key | 5145551 |
| Report Source | CONSUMER |
| Date Received | 2015-10-13 |
| Date of Report | 2015-09-12 |
| Date of Event | 2015-09-12 |
| Date Mfgr Received | 2015-09-12 |
| Date Added to Maude | 2015-10-13 |
| 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 CARE DENTURE ADHESIVE COMPLETE CREME |
| Generic Name | ADHESIVE, DENTURE |
| Product Code | KOO |
| Date Received | 2015-10-13 |
| 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 | 2015-10-13 |