MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-28 for EQUATE SUPER HOLD DENTURE ADHSEIVE manufactured by Sheffield Pharmaceuticals, Llc.
[60929491]
After use of the product, patient claimed his lips swelled. No medical attention sought. Problem went away after stopping use.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1210513-2016-00014 |
| MDR Report Key | 6128787 |
| Date Received | 2016-11-28 |
| Date of Report | 2016-11-28 |
| Date of Event | 2016-10-20 |
| Device Manufacturer Date | 2016-09-06 |
| Date Added to Maude | 2016-11-28 |
| 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 | 3 |
| Brand Name | EQUATE SUPER HOLD DENTURE ADHSEIVE |
| Generic Name | DENTURE ADHESIVE |
| Product Code | KOO |
| Date Received | 2016-11-28 |
| Lot Number | 60261 |
| Device Availability | N |
| 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 | 2016-11-28 |