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 * manufactured by Glaxosmithkline, Consumer Healthcare.
[17898457]
This case was reported by a consumer's family member and described the occurrence of a heart attack in a patient who received super poligrip for denture wearer. The caller initially called to ask about product availability for themselves. A physician or other health care professional has not verified this report. Concomitant medication include polident denture cleanser tablets. On an unknown date, another family member started super poligrip (dental). In 1992, pt experienced a heart attack. An ambulance came but the patient had already died, they were not hospitalized. It is unknown whether an autopsy was performed. The consumer's family member refused to provide any additional information.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2650037-2004-00005 |
| MDR Report Key | 556818 |
| Report Source | 04 |
| Date Received | 2004-11-24 |
| Date of Report | 2004-11-23 |
| Date of Event | 1992-01-01 |
| Date Mfgr Received | 2004-10-27 |
| 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 |
| 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 | DENTCO FACILITY |
| Manufacturer Street | KILOMETER 76.9 |
| Manufacturer City | HUMACAO PR 00791 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00791 |
| 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 | 2004-11-24 |
| 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 | 546486 |
| Manufacturer | GLAXOSMITHKLINE, CONSUMER HEALTHCARE |
| Manufacturer Address | * PARSIPPANY NJ * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2004-11-24 |