MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2014-09-26 for EQUATE DENTURE ADHESIVE manufactured by Sheffield Pharmaceuticals.
[5024565]
The pt/reporter claimed that equate denture adhesive, after she used it for the first time, made her nauseated and vomit. In addition, the product also had a bad smell.
Patient Sequence No: 1, Text Type: D, B5
[12361465]
Reserve sample (30711) with the same lot as the suspect sample was tested for total aerobic plate count and attributes. No issues were identified with the test results.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1210513-2014-00002 |
| MDR Report Key | 4173289 |
| Report Source | 04 |
| Date Received | 2014-09-26 |
| Date of Report | 2014-09-17 |
| Date of Event | 2013-10-31 |
| Device Manufacturer Date | 2013-01-01 |
| Date Added to Maude | 2014-10-16 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Street | 170 BROAD ST. |
| Manufacturer City | NEW LONDON CT 06320 |
| Manufacturer Country | US |
| Manufacturer Postal | 06320 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EQUATE DENTURE ADHESIVE |
| Generic Name | DENTURE ADHESIVE |
| Product Code | KOQ |
| Date Received | 2014-09-26 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SHEFFIELD PHARMACEUTICALS |
| Manufacturer Address | 170 BROAD ST. NEW LONDON CT 06320 US 06320 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-09-26 |