MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2004-11-24 for POLIGRIP ORIGINAL DENTURE ADHESIVE CREAM * manufactured by Glaxosmithkline, Consumer Healthcare.
[423337]
Product evaluation summary: the product wasnot returned to the mfr; however, a retain sample of the lot has been tested. The sample was tested for description, odor, ph and percent gantrez. The results obtained were found to be within specification. No corrective actions have been required based on this report.
Patient Sequence No: 1, Text Type: D, B5
[435137]
Product evaluation summary: the product was not returned to the mfr; however, a retain sample of the lot has been tested. The sample was tested for description, odor, ph and percent gantrez. The results obtained were found to be within specification. No corrective actions have been required based on this report.
Patient Sequence No: 1, Text Type: D, B5
[19153419]
This case was reported by a consumer and described the occurrence of an abnormal ekg-old myocardial infarct in a patient who used poligrip (super poligrip original denture adhesive cream) for loose dentures. The consumer contacted the manufacturer regarding a product complaint. A physician or other health care professional has not verified this report. The patient's past medical history included lung cancer, removal of a lung and rib fractures. Concurrent medical conditions included bipolar disorder and cigarette smoking. Concurrent medications were not specified. On an unknown date, several years ago, the patient, who is a poor historian, started using poligrip (dental). In 2004, the consumer was diagnosed with having a "silent heart attack" as they were told that their electrocardiogram showed evidence of an "old" heart attack. They underwent a cardiac stent procedure the following month and was hospitalized for four days. Treatment with poligrip was continued. The event resolved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9681138-2004-00035 |
| MDR Report Key | 556814 |
| Report Source | 04 |
| Date Received | 2004-11-24 |
| Date of Report | 2004-11-19 |
| Date of Event | 2004-10-16 |
| Date Mfgr Received | 2004-10-29 |
| Device Manufacturer Date | 2004-09-01 |
| Date Added to Maude | 2004-12-01 |
| 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 | GLAXOSMITH KLINE,IRELAND |
| Manufacturer Street | CLOCHERANE |
| Manufacturer City | YOUGAL ROAD DUNGARVAN |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POLIGRIP ORIGINAL DENTURE ADHESIVE CREAM |
| Generic Name | DENTURE ADHESIVE |
| Product Code | KOP |
| Date Received | 2004-11-24 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | X03381 |
| 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 | 546482 |
| Manufacturer | GLAXOSMITHKLINE, CONSUMER HEALTHCARE |
| Manufacturer Address | * PARSIPPANY NJ 07054 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2004-11-24 |