MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2015-09-16 for WALMART EQUATE SUPER HOLD DENTURE ADHESIVE manufactured by Sheffield Pharmaceuticals.
[26604990]
The complaint investigation is still in progress. Suspect sample has not yet been returned to sheffield pharmaceuticals. Sheffield pharmaceuticals is investigating this complaint under (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[26604991]
Reporter complained that her husband became sick, lost (b)(6) pounds and vomiting started using equate super hold denture adhesive cream. She said he has been using the product since (b)(6). She said medical attention has been sought and will be contacting the family doctor. She wants to know what are the side effects of the product because she does not know if the product is causing him to become sick.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1210513-2015-00157 |
| MDR Report Key | 5091559 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2015-09-16 |
| Date of Report | 2015-09-16 |
| Date of Event | 2015-02-01 |
| Date Mfgr Received | 2015-09-11 |
| Device Manufacturer Date | 2015-02-01 |
| Date Added to Maude | 2015-09-21 |
| 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 |
| Generic Name | DENTURE ADHESIVE |
| Product Code | KOO |
| Date Received | 2015-09-16 |
| Lot Number | 50091 |
| 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 | 2015-09-16 |