MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2015-06-25 for WALMART EQUATE DENTURE ADHESIVE .75OZ manufactured by Sheffield Pharmaceuticals.
[6534759]
Patient is stating that the denture adhesive might or might not have caused what looks like black blood blisters on his gums. He is new to dentures and is not sure if these black spots/blisters were there before or after he began using the denture adhesive. He will speak with his dentist to find out what he should do.
Patient Sequence No: 1, Text Type: D, B5
[14498429]
Without the lot code or complaint sample investigation of the complaint issue could not be performed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1210513-2015-00143 |
| MDR Report Key | 4898491 |
| Report Source | 07 |
| Date Received | 2015-06-25 |
| Date of Report | 2015-06-25 |
| Date of Event | 2015-06-01 |
| Date Mfgr Received | 2015-06-01 |
| 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 .75OZ |
| Generic Name | DENTURE ADHESIVE |
| Product Code | KOO |
| Date Received | 2015-06-25 |
| Lot Number | UNK |
| 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 | 2015-06-25 |