MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2004-12-09 for SUPER POLIGRIP * manufactured by Glaxosmithkline.
[313581]
This case was reported by a consumer and desribed the occurrence of new onset diabetes mellitus in a pt who received poligrip (super poligrip-unidentified) cream for loose dentures. The consumer called to praise product, request coupons and make a general product comment. A physician or other health care professional has not verified this report. Concurrent medical conditions included acid reflux, allergic to glucophage, iodine allergy and iodine dye allergy. Concurrent medications included zyrtec and nexium. The pt has been using poligrip (dental) for "twenty to thirty years". In 1994, the pt was diagnosed with new onset diabetes mellitus and treated with insulin lispro (humalog insulin). This case was assessed as medically serious by gsk. Treatment with poligrip was continued. The outcome of the event is ongoing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2650037-2004-00010 |
| MDR Report Key | 559370 |
| Report Source | 04 |
| Date Received | 2004-12-09 |
| Date of Report | 2004-12-08 |
| Date of Event | 1994-01-01 |
| Date Mfgr Received | 2004-11-09 |
| Date Added to Maude | 2004-12-15 |
| 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 | 2004-12-09 |
| 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 | 549078 |
| Manufacturer | GLAXOSMITHKLINE |
| Manufacturer Address | * PARSIPPANY NJ * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-12-09 |