MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-17 for WAL-MART EQUATE SUPER HOLD DENTURE ADHESIVE manufactured by Sheffield Pharmaceuticals.
[42498761]
The complaint investigation is still in process. 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
[42498762]
Patient stated denture adhesive got in her throat and gave her sores in her mouth and bumps on her tongue. Patient states she will call her doctor.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1210513-2015-00158 |
| MDR Report Key | 5569703 |
| Date Received | 2015-11-17 |
| Date of Report | 2015-11-17 |
| Date of Event | 2015-10-29 |
| Device Manufacturer Date | 2015-01-01 |
| Date Added to Maude | 2016-04-12 |
| 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 G1 | SHEFFIELD INDUSTRIES, DIV. OF FARIA LTD. |
| Manufacturer Street | 170 BROAD ST. |
| Manufacturer City | NEW LONDON CT 06320 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 06320 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | WAL-MART EQUATE SUPER HOLD DENTURE ADHESIVE |
| Generic Name | DENTURE ADHESIVE |
| Product Code | KOO |
| Date Received | 2015-11-17 |
| Lot Number | 50031 |
| 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 | 2015-11-17 |