MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2015-07-01 for WALMART EQUATE DENTURE ADHESIVE manufactured by Sheffield Industries, Div. Of Faria Ltd..
[6021053]
Patient states that the product caused her to get blisters inside her mouth. She also states that this has never happened to her before.
Patient Sequence No: 1, Text Type: D, B5
[14251276]
Complaint investigation still in progress. Suspect sample has not yet been returned to sheffield pharmaceuticals.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1210513-2015-00144 |
| MDR Report Key | 4899089 |
| Report Source | 07 |
| Date Received | 2015-07-01 |
| Date of Report | 2015-07-01 |
| Date of Event | 2015-06-12 |
| Date Mfgr Received | 2015-06-17 |
| Device Manufacturer Date | 2015-02-01 |
| Date Added to Maude | 2015-07-14 |
| 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 |
| Manufacturer Phone | 8604424451 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WALMART EQUATE DENTURE ADHESIVE |
| Generic Name | DENTURE ADHESIVE |
| Product Code | KOO |
| Date Received | 2015-07-01 |
| Lot Number | 50161 |
| Operator | LAY USER/PATIENT |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SHEFFIELD INDUSTRIES, DIV. OF FARIA LTD. |
| Manufacturer Address | NEW LONDON CT 06320 US 06320 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-07-01 |