MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-05-13 for FIXODENT DENTURE ADHESIVE, VERSION UNKNOWN manufactured by Procter & Gamble Manufacturing Co..
[144999476]
Reporter used the product for their dental bridge, which is an unapproved use. Dental cream is designed to be used only for full and partial dentures, per label. Consumer claimed their dental bridge dislodged and they ingested the dental bridge resulting in surgery. Product return was requested and a follow-up questionnaire has been sent to the reporter, but neither have 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
[144999497]
Bridge hooked into intestines [foreign body in gastrointestinal tract], nearly lost my appendix [appendix disorder], securing dental bridge with fixodent, is not effective to secure dental bridge [therapeutic product ineffective for unapproved indication], bridge came out and swallowed it (fixodent not effective to secure bridge) [accidental device ingestion], bridge came out and swallowed it [exposure via ingestion]. Case description: a consumer, unspecified age and gender, reported spontaneously via e-mail on 01-apr-2019 that he/she had a dental bridge that was secured with fixodent denture adhesive, version unknown. On (b)(6) 2017, his/her bridge came out while eating dinner and he/she swallowed it. He/she went to the er. A week later, he/she went to have the bridge surgically removed through his/her stomach. The bridge was hooked into his/her intestines and he/she nearly lost his/her appendix. Relevant history: hist drug/prev exp: fixodent (used your product for years). Concomitant product(s): none reported. The case outcome was recovered. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1530449-2019-00001 |
| MDR Report Key | 8604475 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-05-13 |
| Date of Report | 2019-04-01 |
| Date of Event | 2017-05-18 |
| Date Mfgr Received | 2019-06-28 |
| Date Added to Maude | 2019-05-13 |
| 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 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 DENTURE ADHESIVE, VERSION UNKNOWN |
| Generic Name | ADHESIVE, DENTURE |
| Product Code | KOO |
| Date Received | 2019-05-13 |
| Lot Number | NOT AVAILABLE |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| 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 | 2019-05-13 |