MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-23 for EQUATE DENTURE ADHESIVE manufactured by Sheffield Pharmaceuticals, Llc.
[52839924]
(b)(6) used the equate denture adhesive cream and it caused her to throw up, have nausea and her mouth to swell. She was going to seek medical attention. Repeated attempts to reach her have been unsuccessful.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1210513-2016-00012 |
| MDR Report Key | 5897694 |
| Date Received | 2016-08-23 |
| Date of Report | 2016-08-23 |
| Date of Event | 2016-08-06 |
| Date Added to Maude | 2016-08-23 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | EQUATE DENTURE ADHESIVE |
| Generic Name | DENTURE ADHESIVE |
| Product Code | KOO |
| Date Received | 2016-08-23 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SHEFFIELD PHARMACEUTICALS, LLC |
| Manufacturer Address | 170 BROAD ST NEW LONDON CT 06320 US 06320 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-08-23 |