MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2015-07-30 for WALMART EQUATE COMPLETE DENTURE ADHESIVE manufactured by Sheffield Pharmaceuticals.
[6254591]
Patient complained that denture adhesive caused her to have a pus filled lesion on her tongue. She also stated that it reminds her of a canker sore and it burns. She may seek medical attention. Patient is 8 1/2 month pregnant.
Patient Sequence No: 1, Text Type: D, B5
[14085681]
Complaint investigation still in process. Suspect sample has not yet been returned to sheffield pharmaceuticals. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1210513-2015-00148 |
| MDR Report Key | 4961105 |
| Report Source | 07 |
| Date Received | 2015-07-30 |
| Date of Report | 2015-07-29 |
| Date of Event | 2015-07-13 |
| Date Mfgr Received | 2015-07-20 |
| Device Manufacturer Date | 2015-02-01 |
| Date Added to Maude | 2015-08-04 |
| 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 COMPLETE DENTURE ADHESIVE |
| Generic Name | DENTURE ADHESIVE |
| Product Code | KOO |
| Date Received | 2015-07-30 |
| Lot Number | 50232 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SHEFFIELD PHARMACEUTICALS |
| Manufacturer Address | NEW LONDON CT 06320 US 06320 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-07-30 |