MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-05-25 for FIXODENTDENTURECAREDENTUREADHESIVEFOODSEALCRMNOFLAVORSCENT manufactured by Proctor & Gamble Manufacturing Co..
[75964643]
Invalid lot number/day code provided by reporter. Based on the information given and the absence of the valid day code, this complaint could not be investigated. Should sample be received, the investigation will be re-evaluated to determine if any additional steps are required.
Patient Sequence No: 1, Text Type: N, H10
[75964644]
Tongue swollen [swollen tongue]; swollen mouth [mouth swelling]; lips swollen [lip swelling]; swelling jaws [swelling face]; swelling/ glands on sides of neck [lymphadenopathy]; gums reddened [gingival erythema]; tongue red [tongue erythema]; tiny black spots/ bottom lip [lip disorder]; tongue raw [glossitis]; painful/hurts - entire mouth [oral pain]; soreness/ jaws [pain in jaw]. Case description: a (b)(6) year old female reported via phone using fixodent denture care denture adhesive food seal cream no flavor-scent for the first time beginning towards the evening of (b)(6) 2017 through (b)(6) 2017, as directed on the top and bottom denture once a day, and when she woke up the next morning ((b)(6) 2017), her mouth, lips, tongue, jaws and glands were swollen, her gums were reddened, and her tongue was red and raw. She stated that she used some swish and swallow medicated liquid that she had at home (oral swish and swallow antibiotic that is used for treating thrush) and tried to use her dentures again but her entire mouth was becoming painful and there was soreness in her jaws. She reported that the swelling continued in her tongue, lips and jaws, so she proceeded to take the dentures out and used the swish and swallow again and took some benadryl by mouth. She stated that she immediately called her doctor and told him that she had an epipen for her latex allergy. She reported that he said to administer the epipen to herself and if that didn't help to call 911. She stated that it did help and she did not want to go to the hospital. She described that her symptoms have improved some, but she still can't eat, so a relative is going to take her into urgent care today. She reported that her entire mouth still hurts, her tongue and gums are red, and she has tiny black spots on her bottom lip, which appeared a day after her first use ((b)(6) 2017). She stated that she had been using polygrip and it wasn't working that well, so her dentist recommended fixodent. She asserted that the label should state in bigger lettering that the product contains zinc. Relevant history: allergy-latex; drug allergy-none reported; medical history-none reported; concomitant medication-none reported. The overall case outcome was improved. No further information was provided. On 10-may-2017 product investigation results received: [conclusion code]: no cause determined - insufficient information to investigate further. [summary]: production records in sap confirm the production lot code/product version combination is not complete & legitimate for fixodent/denture care/denture adhesive/ food seal/cream/no flavor-scent, the day code provided is invalid. Product was not returned to the manufacturing plant. Conclusion: the day code provided was invalid. Without a valid day code we cannot conduct an investigation, based on the information given and the absence of the valid day code, this complaint could not be investigated. Should sample be received subsequent to this review, the investigation will be re-evaluated to determine if any additional steps are required. This investigation is closed. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1530449-2017-00005 |
| MDR Report Key | 6590215 |
| Report Source | CONSUMER |
| Date Received | 2017-05-25 |
| Date of Report | 2017-05-01 |
| Date of Event | 2017-04-29 |
| Date Mfgr Received | 2017-05-01 |
| Date Added to Maude | 2017-05-25 |
| 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 | FIXODENTDENTURECAREDENTUREADHESIVEFOODSEALCRMNOFLAVORSCENT |
| Generic Name | ADHESIVE, DENTURE |
| Product Code | KOO |
| Date Received | 2017-05-25 |
| Lot Number | 71129 |
| ID 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 | PROCTOR & GAMBLE MANUFACTURING CO. |
| Manufacturer Address | BROWN SUMMIT NC US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-05-25 |