MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2005-06-22 for SUPER POLIGRIP FREE DENTURE ADHESIVE CREAM * manufactured by Glaxosmithkline Consumer Healthcare.
[381190]
This case was reported by a consumer and described the occurrence of swollen tongue in a pt who received poligrip (super poligrip free denture ahesive cream) for loose dentures. The purpose of the call was to ask about allergic reactions associated with poligrip. A physician or other health care professional has not verified this report. Concurrent medical conditions included high blood pressure, elevated cholesterol and osteoarthritis. Co-suspect medications included lisinopril, pravachol, lipitor and verapamil. Concurrent medications included baby aspirin. In approximately 2003 the pt started super poligrip (dental) in 2004, the pt experienced an episode of swelling of the tongue and throat. The pt was hospitalizsed for 3 days. Pt was treated with steroids. The events resolved. Treatment with super poligrip was continued but pt was taken off all previous routine medications (lisinopril, pravachol, baby aspirin) for one month. The events re-occurred during the month pt was off the medications. After being off all medications for one month, the pt was started on new medications for their blood pressure (verapamil) and for their cholesterol (lipitor). The events re-occurred after starting these new medications. The events re-occurred four times after the initial episode with the most recent episode having occurred in may 2005. The pt was hospitalized overnight and treated with steroids each time. The events resolved each time. Treatment with super poligrip continued unitl after the last episode in may 2005. Pt has no experienced an episode since discontinuing super poligrip. Pt is being medically managed with prednisone 20 mg daily, zyrtec, and zantac while their diangostic work-up for the cause of the events continues. Pt plans to return to using super poligrip because pt discovered fixodent does not work as well. Their doctors do not suspect a correlation between the events and their medications, including super poligrip.
Patient Sequence No: 1, Text Type: D, B5
[406201]
Product evaluation summary: the unused product was not returned to the manufacturer; however, a retain sample from the same lot number was evaluated. Evaluation included appearance and ph and were found to be within specifications. The lot number met all requirement of release specifications at the time of release. No corrective actions are required based on this report. Manufacturer's comment; lisinopril, pravachol, verapamil, and lipitor are no longer considered co-suspect medications.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9681138-2005-00005 |
| MDR Report Key | 616824 |
| Report Source | 04 |
| Date Received | 2005-06-22 |
| Date of Report | 2005-06-22 |
| Date of Event | 2004-12-02 |
| Date Mfgr Received | 2005-06-01 |
| Device Manufacturer Date | 2004-11-01 |
| Date Added to Maude | 2005-06-27 |
| 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 RD. |
| Manufacturer City | PARRISPANY NJ 07054 |
| Manufacturer Country | US |
| Manufacturer Postal | 07054 |
| Manufacturer Phone | 9738892494 |
| Manufacturer G1 | GLAXOSMITHKLINE,IRELAND |
| Manufacturer Street | CLOCHERANE, YOUGHAL ROAD |
| Manufacturer City | DUNGARVAN |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUPER POLIGRIP FREE DENTURE ADHESIVE CREAM |
| Generic Name | DENTURE ADHESIVE |
| Product Code | KOP |
| Date Received | 2005-06-22 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | R04474 |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 606551 |
| Manufacturer | GLAXOSMITHKLINE CONSUMER HEALTHCARE |
| Manufacturer Address | * PARSIPPANY NJ * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2005-06-22 |