MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-02-06 for POLY-GRIP * manufactured by Block Drug, Inc..
[18335140]
For years pt used the dental adhesive with no problems. Last 3 tubes she purchased are new improved and she experienced severe reactions. Red swollen eyes, loss of taste, headaches, throat, closing, redness of tongue, and now stomach aches. Her dr did many tests, all returned normal results. Pt is scheduled for some intestinal tests next. Her dr told her to stop using the adhesive. Since there is no ingredients labeled on the packaging of the product, she could be allergic to them.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4001763 |
| MDR Report Key | 67190 |
| Date Received | 1997-02-06 |
| Date of Report | 1997-01-13 |
| Date Added to Maude | 1997-02-10 |
| 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 |
| 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 | POLY-GRIP |
| Generic Name | DENTAL ADHESIVE |
| Product Code | KOP |
| Date Received | 1997-02-06 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 67225 |
| Manufacturer | BLOCK DRUG, INC. |
| Manufacturer Address | 257 CORNELISON AVE JERSEY CITY NJ 07302 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-02-06 |