MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-22 for FIXODENT ADHESIVE ORIGINAL CREAM, NO FLAVOR manufactured by Procter & Gamble Manufacturing Co..
[145929322]
Product return was requested and a follow-up questionnaire has been sent to the reporter, but neither has been received at this time. As a valid production code has not been provided by the reporter, no further product investigation is possible at this time. Further evaluation will occur upon receipt of the consumer product and/or the questionnaire.
Patient Sequence No: 1, Text Type: N, H10
[145929323]
Fixodent stuck in esophagus [foreign body in gastrointestinal tract]. Vomiting, pink sticky stuff in vomit [vomiting]. Nausea [nausea]. Fixodent does not hold well [device ineffective]. Sometimes apply fixodent twice a day [device used for unapproved schedule]. Case description: a spontaneous report was received via phone on 22-apr-2019 from a (b)(6) year old female consumer stating she used fixodent adhesive original cream, no flavor, and she currently had 2 tubes of fixodent denture care denture adhesive original cream no flavor-scent. 75oz, to hold her bottom partial denture beginning on an unspecified date, and experienced nausea and vomiting beginning on an unspecified date. She reported she followed the instructions for use on the product box, but the product did not hold well. The hold would disappear after a few hours, and sometimes she had to apply the product twice a day. She visited a doctor who performed an endoscopy, and fixodent was found stuck in her esophagus. The consumer reported the doctor said this was the cause of the nausea and vomiting, and the consumer had noticed pink sticky stuff in her vomit as well. She stated the fixodent was cleaned from her esophagus, and she was given medication for nausea. The outcome of fixodent stuck in esophagus was recovered. The outcomes of nausea and vomiting were improved. The case outcome was improved. Medical history: denture wearer (partial denture). The consumer reported her last denture fitting was 2 years ago, and her denture fit well. Concomitant product(s): none reported. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1530449-2019-00002 |
| MDR Report Key | 8632535 |
| Date Received | 2019-05-22 |
| Date of Report | 2019-04-22 |
| Date Mfgr Received | 2019-04-22 |
| Date Added to Maude | 2019-05-22 |
| 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 RD |
| 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 | 0 |
| Brand Name | FIXODENT ADHESIVE ORIGINAL CREAM, NO FLAVOR |
| Generic Name | ADHESIVE, DENTURE |
| Product Code | KOO |
| Date Received | 2019-05-22 |
| 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. Required No Informationntervention | 2019-05-22 |