MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2015-08-26 for WALMART EQUATE DENTURE ADHESIVE 0.75 OZ manufactured by Sheffield Pharmaceuticals.
[25283770]
The complaint investigation still in process. Suspect sample has not yet been returned to sheffield (b)(4). Sheffield (b)(4) is investigating this complaint under complaint #(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[25283771]
Customer complained that the product caused her to break out in hives in her mouth and have dizziness. She may seek medical attention.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1210513-2015-00151 |
| MDR Report Key | 5048622 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2015-08-26 |
| Date of Report | 2015-08-11 |
| Date of Event | 2015-07-28 |
| Date Mfgr Received | 2015-07-28 |
| Device Manufacturer Date | 2015-02-01 |
| Date Added to Maude | 2015-09-02 |
| 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 DENTURE ADHESIVE 0.75 OZ |
| Product Code | KOO |
| Date Received | 2015-08-26 |
| Lot Number | 50243 |
| 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 | 2015-08-26 |