MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-12-06 for FIXODENTDENTURECAREDENTUREADHESIVEEXTSUPERHOLDPWDNOFLAVORSCENT2.7OZ manufactured by Procter & Gamble Manufacturing Co..
[93835269]
Lot number or product was not provided by the reporter.
Patient Sequence No: 1, Text Type: N, H10
[93835270]
Throat swelled [pharyngeal oedema]. Trouble breathing [dyspnoea]. Allergic [hypersensitivity]. Sick to stomach/nauseous [nausea]. Feeling off [feeling abnormal]. Case description: a consumer, gender and age unspecified, provided a spontaneous report via e-mail on (b)(6) 2017 that he/she was a new denture wearer and was supplied with an immediate denture. He/she stated that until a reline could be performed, he/she needed some adhesive to keep the denture fitting correctly and used fixodent denture care denture adhesive extra-super hold powder on an unknown date and was highly allergic. Product use was withdrawn on an unknown date. Treatment details: unknown; relevant history: none reported; concomitant product(s): none reported. The overall case outcome was unknown. No further information was provided. (b)(6) 2017 consumer follow-up: the consumer reported that he/she had to use adhesive until his/her reline could be completed so tried fixodent powder and his/her throat swelled and he/she had trouble breathing. The consumer stated that a doctor gave him/her an epi-pen because it was so bad. Treatment details: unknown; relevant history: medical history-crohn's disease; concomitant product(s): none reported. The overall case outcome remained unknown. No further information was provided. On (b)(6) 2017 update: it was learned that the consumer contacted the company on (b)(6) 2017 via spontaneous email to report that he/she was a recent denture wearer as well as a crohn's sufferer, and was unable to use the soft reline material from his/her dentist due to an allergy, so he suggested denture adhesive. The consumer stated that he/she did research and purchased fixodent/denture care denture adhesive extra-super hold powder no flavor-scent thinking it was zinc free in early (b)(6) 2017. The consumer described that he/she has been sick to his/her stomach, nauseous, and feeling off for weeks and could not figure out why. The consumer stated that he/she checked the bottle and discovered it had zinc in it. The consumer asserted it was frustrating to need a product that he/she can't use. The case outcome was unknown. No further information was provided. On 30-nov-2017 update: it was additionally learned during the (b)(6) 2017 contact that the consumer tried the fixodent complete originai cream after use of the fixodent/denture care denture adhesive extra-super hold powder no flavor-scent and did not have throat issues with that product. The case outcome was improved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1530449-2017-00007 |
| MDR Report Key | 7086084 |
| Report Source | CONSUMER |
| Date Received | 2017-12-06 |
| Date of Report | 2017-11-13 |
| Date Mfgr Received | 2017-11-14 |
| Date Added to Maude | 2017-12-06 |
| 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 Country | US |
| 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 | FIXODENTDENTURECAREDENTUREADHESIVEEXTSUPERHOLDPWDNOFLAVORSCENT2.7OZ |
| Generic Name | ADHESIVE, DENTURE |
| Product Code | KOO |
| Date Received | 2017-12-06 |
| Lot 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 | 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 | 2017-12-06 |