MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-04-19 for SUPER POLYGRIP * manufactured by Block Drug Co Inc.
[225951]
The complainant wanted to know the ingredients in super polygrip because they sometimes swallow this denture adhesive. Since the product is considered to be a device, they found no ingredient statement on the label. Called the co and they refused to tell complainant the ingredients. Complainant thinks that the fda should sponsor legal changes to require the listing of ingredients on oral devices which are not intact pieces like other devices.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4002987 |
| MDR Report Key | 328554 |
| Date Received | 2001-04-19 |
| Date of Report | 2001-04-02 |
| Date Added to Maude | 2001-04-26 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUPER POLYGRIP |
| Generic Name | DENTURE ADHESIVE |
| Product Code | KOM |
| Date Received | 2001-04-19 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 317947 |
| Manufacturer | BLOCK DRUG CO INC |
| Manufacturer Address | 257 CORNELISON AVE JERSEY CITY NJ 073023198 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2001-04-19 |