MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-01-08 for WALMART EQUATE COMPLETE DENTURE ADHESIVE CREAM TWIN PK manufactured by Sheffield Pharmaceuticals.
[37338771]
The complaint investigation is still in progress. Suspect sample has not yet been returned to sheffield pharmaceuticals. Sheffield pharmaceuticals is investigating this complaint under complaint (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[37338772]
Pt stated (b)(6) equate complete original denture adhesive was too strong and tore her gums after she could not get denture out her mouth for three days. Pt has not sought any medical attention for her condition.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1210513-2015-00161 |
| MDR Report Key | 5384834 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2016-01-08 |
| Date of Report | 2016-01-08 |
| Date of Event | 2015-12-21 |
| Date Mfgr Received | 2015-12-29 |
| Date Added to Maude | 2016-01-22 |
| 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 |
| Manufacturer Street | 170 BROAD ST. |
| Manufacturer City | NEW LONDON CT 06320 |
| Manufacturer Country | US |
| Manufacturer Postal | 06320 |
| Manufacturer Phone | 8404424451 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | WALMART EQUATE COMPLETE DENTURE ADHESIVE CREAM TWIN PK |
| Product Code | KOO |
| Date Received | 2016-01-08 |
| Lot Number | UNK |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| 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 | 2016-01-08 |