MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-01-21 for WALMART EQUATE SUPER HOLD DENTURE ADHESIVE CREAM 2.4 OZ manufactured by Sheffield Pharmaceuticals.
[37339017]
The complaint investigation is still in progress. Suspect sample has not yet been returned to sheffield pharmaceuticals. Sheffield pharmaceuticals is investigation this complaint under complaint (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[37339018]
Pt stated when she used equate denture adhesive she got hives. Pt wanted to know what the side effects were. This event occurred in (b)(6)2015, but was not reported to walmart until (b)(6) 2016.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1210513-2015-00162 |
| MDR Report Key | 5404332 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2016-01-21 |
| Date of Report | 2016-01-21 |
| Date of Event | 2015-07-07 |
| Date Mfgr Received | 2016-01-08 |
| Device Manufacturer Date | 2015-02-04 |
| Date Added to Maude | 2016-02-02 |
| 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 | 8604424451 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | WALMART EQUATE SUPER HOLD DENTURE ADHESIVE CREAM 2.4 OZ |
| Product Code | KOO |
| Date Received | 2016-01-21 |
| Lot Number | 50611 |
| 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 | 2016-01-21 |