MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2004-06-15 for POLIGRIP * manufactured by Glaxosmithkline Consumer Healthcare, Medical Affairs, Us Product Safety.
[319996]
Occurrence of an abnormal ekg due to an old myocardial infarct in a consumer who uses poligrip (super poligrip original denture adhesive cream) paste for loose dentures. A physician or other health care professional has not verified this report. The pt's past medical history included cigarette smoker. Pt has been using the poligrip (super poligrip original denture adhesive cream) paste daily for about five to ten years and in 2002, had an abnormal electrocardiogram which was attributed to an asymptomatic heart attrack. They underwent a triple coronary artery bypass surgery. They continue to use the poligrip (super poligrip original denture adhesive cream) daily. Manufacturer comment: super poligrip original denture adhesive cream was manufactured in dungarvan, ireland and neither the lot number nor the product are available. No corrective actions have been required based on this report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9681138-2004-00008 |
| MDR Report Key | 530157 |
| Report Source | 04 |
| Date Received | 2004-06-15 |
| Date of Report | 2004-05-25 |
| Date of Event | 2002-01-01 |
| Date Mfgr Received | 2004-04-16 |
| Date Added to Maude | 2004-06-18 |
| 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 | PARSIPPANY NJ 070543884 |
| Manufacturer Country | US |
| Manufacturer Postal | 070543884 |
| Manufacturer Phone | 9738892494 |
| Manufacturer G1 | GLAXOSMITHKLINE, IRELAND |
| Manufacturer Street | CLOHERANE YOUGHAL RD |
| 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 | 2004-06-15 |
| 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 | A |
| Device Sequence No | 1 |
| Device Event Key | 519385 |
| Manufacturer | GLAXOSMITHKLINE CONSUMER HEALTHCARE, MEDICAL AFFAIRS, US PRODUCT SAFETY |
| Manufacturer Address | 1500 LITTLETON ROAD PARSIPPANY NJ 070543884 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2004-06-15 |