MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2015-06-22 for EQUATE COMPLETE ORIGINAL DENTURE ADHESIVE manufactured by Sheffield Pharmaceuticals.
[5864174]
Consumer complained that after using the equate adhesive it took him 15 minutes to remove the adhesive from dentures and his gums were sticky, gooey and swollen with irritation to his gum.
Patient Sequence No: 1, Text Type: D, B5
[13700456]
Manufacturing review, adhesion test.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1210513-2015-00141 |
| MDR Report Key | 4872428 |
| Report Source | 07 |
| Date Received | 2015-06-22 |
| Date of Report | 2015-06-16 |
| Date of Event | 2015-05-27 |
| Date Mfgr Received | 2015-05-28 |
| Device Manufacturer Date | 2015-03-01 |
| Date Added to Maude | 2015-07-01 |
| 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 Contact | SHEFFIELD PHARMACEUTICALS |
| Manufacturer Street | 170 BROAD ST. |
| Manufacturer City | NEW LONDON CT 06320 |
| Manufacturer Country | US |
| Manufacturer Postal | 06320 |
| Manufacturer Phone | 8604424451 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EQUATE COMPLETE ORIGINAL DENTURE ADHESIVE |
| Generic Name | DENTURE ADHESIVE |
| Product Code | KOO |
| Date Received | 2015-06-22 |
| Returned To Mfg | 2015-06-15 |
| Lot Number | 50351 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SHEFFIELD PHARMACEUTICALS |
| Manufacturer Address | NEW LONDON CT US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-06-22 |