MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2004-06-25 for POLIDENT * manufactured by Glaxosmithkline Consumer Healthcare/med Affairs, Us Product Safety.
[15443066]
This case was reported from a nursing home and described the occurrence of aspiration pneumonia in a pt who had accidentally ingested polident denture cleanser. A physician or other health care professional has not verified this report. Concurrent medical conditions included interstitial pneumonia, dementia and lung cancer. The pt had been in a residential care setting since 2003. Sixteen days later at 18:00 the pt had accidentally ingested an unk quantity of polident. An exam by a physician showed no untoward signs. On a subsequent exam the following day the customer was diagnosed with aspiration pneumonia and was hospitalized. The consumer died twenty-three days later. No corrective actions have been required based on this report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9681138-2004-00012 |
| MDR Report Key | 531556 |
| Report Source | 01 |
| Date Received | 2004-06-25 |
| Date of Report | 2004-05-23 |
| Date of Event | 2004-01-12 |
| Date Mfgr Received | 2004-01-26 |
| Date Added to Maude | 2004-06-29 |
| 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 ROAD |
| Manufacturer City | PARSIPPANY NJ 070543884 |
| Manufacturer Country | US |
| Manufacturer Postal | 070543884 |
| Manufacturer Phone | 9738892494 |
| Manufacturer G1 | GLAXOSMITHKLINE, IRELAND |
| Manufacturer Street | YOUGHAL ROAD |
| Manufacturer City | DUNGARVIN |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POLIDENT |
| Generic Name | DENTURE ADHESIVE |
| Product Code | KOP |
| Date Received | 2004-06-25 |
| 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 | 520801 |
| Manufacturer | GLAXOSMITHKLINE CONSUMER HEALTHCARE/MED AFFAIRS, US PRODUCT SAFETY |
| Manufacturer Address | 1500 LITTLETON ROAD PARSIPPANY NJ 070543884 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Hospitalization; 3. Life Threatening | 2004-06-25 |