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 Customer Healthcare.
[383551]
On an unknown date, the pt started using super poligrip (dental). In 1998, the pt died. The cause of death is unknown and it is also unknown if an autopsy was performed. There is no further information available. The customer refused to provide additional information.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2650037-2004-00011 |
| MDR Report Key | 565909 |
| Report Source | 04 |
| Date Received | 2005-01-14 |
| Date of Report | 2005-01-13 |
| Date of Event | 1998-01-01 |
| 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 |
| 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 | 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 | 555697 |
| Manufacturer | GLAXOSMITHKLINE CUSTOMER HEALTHCARE |
| Manufacturer Address | * PARSIPPANY NJ 07054 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2005-01-14 |