MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2015-08-20 for WALMART EQUATE FIRM HOLD DENTURE ADHESIVE 2.4 manufactured by Sheffield Pharmaceuticals.
[24223455]
Sheffield pharmaceuticals is investigating this complaint under (b)(4). Evaluation summary: the testing was performed and the results of both the reserve and suspect sample did not identify any issues.
Patient Sequence No: 1, Text Type: N, H10
[24223456]
Patient stated that the product caused blisters on the roof of her mouth. Adhesive held so hard it was difficult to remove denture and it hurts the roof of her mouth which is bruised and she has a few lesions. She only used adhesive for 1 week before issue occurred. She will seek medical attention.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1210513-2015-00153 |
| MDR Report Key | 5028071 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2015-08-20 |
| Date of Report | 2015-08-20 |
| Date of Event | 2015-05-07 |
| Date Mfgr Received | 2015-05-13 |
| Device Manufacturer Date | 2014-11-01 |
| Date Added to Maude | 2015-08-25 |
| 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 FIRM HOLD DENTURE ADHESIVE 2.4 |
| Product Code | KOO |
| Date Received | 2015-08-20 |
| Returned To Mfg | 2015-06-01 |
| Lot Number | 40111 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2015-08-20 |