MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2004-12-02 for POLIGRIP * manufactured by Glaxosmithkline.
[14873754]
This case was reported by a consumer and described the occurrence of addisonian crisis in a pt who received poligrip (super poligrip original denture adhesive cream) cream for loose dentures. The consumer called to report a product quality issue on a tube of super poligrip not involved with the event. A physician or other health care professional has not verified this report. The pt's past medical history included phlebitis. Concurrent medical conditions included addison's disease, hypertension, hypothyroidism and macular degeneration. Concurrent medications included florinef, thyroid medication, coumadin, salt, propranolol, captopril and norvasc. In 08/2004 the pt started poligrip (dental). Two months later, the pt experienced diarrhea and weakness and was hospitalized for 5 days where pt was diagnosed with an exacerbation of addison's disease. The pt was treated with iv cortisone. Treatment with poligrip was continued. The events resolved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9681138-2004-00032 |
| MDR Report Key | 558885 |
| Report Source | 04 |
| Date Received | 2004-12-02 |
| Date of Report | 2004-11-30 |
| Date of Event | 2004-10-01 |
| Date Mfgr Received | 2004-11-12 |
| Date Added to Maude | 2004-12-13 |
| 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 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Street | 1500 LITTLETON ROAD |
| Manufacturer City | PARSIPPANY NJ 07054 |
| Manufacturer Country | US |
| Manufacturer Postal | 07054 |
| Manufacturer Phone | 9738892494 |
| Manufacturer G1 | GLAXOSMITHKLINE, IRELAND |
| Manufacturer Street | CLOCHERANE, YOUGHAL ROAD |
| Manufacturer City | DUNGARVIN |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POLIGRIP |
| Generic Name | DENTURE ADHESIVE |
| Product Code | KOP |
| Date Received | 2004-12-02 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | UNK |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 548579 |
| Manufacturer | GLAXOSMITHKLINE |
| Manufacturer Address | * PARSIPPANY NJ * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2004-12-02 |