MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2004-12-14 for SUPER POLIGRIP EXTRA CARE W/POLISEAL CREAM * manufactured by Glaxosmithkline Consumer Healthcare.
[342555]
This case was reported by a consumer and described the occurrence of carotid artery occlusion in a pt who used super poligrip extra care with poliseal denture adhesive cream for loose dentures. The consumer called with a product question. A physician or other health care professional has not verified this report. The pt's past medical history included smoking. Concurrent medical conditions included arthritis and high cholesterol. Concurrent medications included super poligrip original denture adhesive cream, super poligrip free denture adhesive cream, lovastatin, hydrochlorothiazide + spironolactone, hydrocodone and vitamin e. On an unknown date the pt started using super poligrip extra care with poliseal denture adhesive cream and had been feeling "sick to their stomach" on and off 3 or 4 times a week for the past 4 to 5 years. In 2002, the pt was diagnosed with carotid artery occlusion and had neck surgery. Also in 2003 they had eye surgery (nos). On the date of the report the pt was feeling nauseated. Treatment with super poligrip was continued. The carotid artery occlusion resolved and the nausea and feeling sick are unresolved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9681138-2004-00040 |
| MDR Report Key | 559353 |
| Report Source | 04 |
| Date Received | 2004-12-14 |
| Date of Report | 2004-12-10 |
| Date of Event | 2002-01-01 |
| Date Mfgr Received | 2004-11-11 |
| Date Added to Maude | 2004-12-15 |
| 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 |
| 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 EXTRA CARE W/POLISEAL CREAM |
| Generic Name | DENTURE ADHESIVE |
| Product Code | KOP |
| Date Received | 2004-12-14 |
| 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 | 549061 |
| Manufacturer | GLAXOSMITHKLINE CONSUMER HEALTHCARE |
| Manufacturer Address | * PARSIPPANY NJ 07054 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other; 3. Required No Informationntervention | 2004-12-14 |