MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2005-01-14 for SUPER POLIGRIP * manufactured by Glaxosmithkline Consumer Healthcare.
[17828842]
On an unk date, the pt started using super poligrip (dental) (nos). At an unk time after starting poligrip, the pt experienced unspecified leg circulation problems and was taken to the er since pt could not walk. Pt was hospitalized for 1 month. At an unk time the pt slipped into a coma and became ventilator dependent. Pt subsequentely died on an unk date. The pt died, cause of death is unk. No autopsy was performed. The reporter did not have knowledge of details of the pt's medical condition (s) or treatments.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2650037-2004-00013 |
| MDR Report Key | 565910 |
| Report Source | 04 |
| Date Received | 2005-01-14 |
| Date of Report | 2005-01-13 |
| Date Mfgr Received | 2004-12-23 |
| Date Added to Maude | 2005-01-19 |
| 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 07054 |
| Manufacturer Country | US |
| Manufacturer Postal | 07054 |
| Manufacturer Phone | 9738892494 |
| Manufacturer G1 | DENTCO FACILITY |
| Manufacturer Street | PR STATE RD #3 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 | SUPER POLIGRIP |
| Generic Name | DENTURE ADHESIVE |
| Product Code | KOP |
| Date Received | 2005-01-14 |
| 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 | 555698 |
| Manufacturer | GLAXOSMITHKLINE CONSUMER HEALTHCARE |
| Manufacturer Address | * PARSIPPANY NJ 07054 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Hospitalization; 3. Deathisabilit | 2005-01-14 |