MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-06-29 for SUPER POLYGRIP manufactured by Block Drug Co..
[150075]
Pt developed an inflamed mouth and hives in stomach after using the product. Pt stated that they did not have any problems with polygrip free adhesive that was previously being marketed. Pt also wants to know why there is no ingredient statement on the box or tube so they can try to figure out what they are allergic to. Pt stated that previously they developed an inflamed mouth after using fix-o-dent adhesive. Pt developed diarrhea and other symptoms mentioned 72-96 hrs after use. Pt saw physician and was admitted to hosp for treatment with lomotil and prednisone.
Patient Sequence No: 1, Text Type: D, B5
[255210]
Add'l info rec'd from mfr 09/28/01: the results of tests conducted on the batch before and after packaging showed full compliance with specifications.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4002805 |
| MDR Report Key | 284734 |
| Date Received | 2000-06-29 |
| Date of Report | 2000-06-28 |
| Date of Event | 2000-06-01 |
| Date Added to Maude | 2000-07-10 |
| 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 |
| 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 2.4 OZ PLASTIC TUBE |
| Product Code | KOP |
| Date Received | 2000-06-29 |
| Model Number | NA |
| Catalog Number | NI |
| Lot Number | HK099 |
| ID Number | PURCHASE DATE 5/00 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 275544 |
| Manufacturer | BLOCK DRUG CO. |
| Manufacturer Address | 257 CORNELISON AVE. JERSEY CITY NJ 073023198 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2000-06-29 |