MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2005-01-07 for SUPER POLIGRIP ULTRA FRESH * manufactured by Glaxosmithkline.
[393248]
This case was reported by a consumer and described the occurrence of pneumonia in a pt who received poligrip (super poligrip ultra fresh denture adhesive cream) cream over a period of 3 years for loose dentures. The consumer called to ask a product question. A physician or other health care professional has not verified this report. Concurrent illness included chronic obstructive pulmonary disease. About three years ago the pt stated poligrip (dental). In 2004 the pt experienced pneumonia, weakness and shortness of breath. This case was assessed as medically serious by gsk. Treatment for the pneumonia is unknown. Treatment with poligrip was continued. The pneumonia resolved and the weakness and shortness of breath are unresolved. The pt refused to provide identifying information. The lot number for this product is available and quality test is pending.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9681138-2004-00045 |
| MDR Report Key | 564509 |
| Report Source | 04 |
| Date Received | 2005-01-07 |
| Date of Report | 2004-12-17 |
| Date of Event | 2004-11-01 |
| Date Mfgr Received | 2004-12-13 |
| Device Manufacturer Date | 2004-05-01 |
| Date Added to Maude | 2005-01-12 |
| 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 | GLAXOSMITHKLINE,IRELAND |
| Manufacturer Street | CLOCHERANE, YOUGHAL ROAD |
| Manufacturer City | DUNGARVAN |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUPER POLIGRIP ULTRA FRESH |
| Generic Name | DENTURE ADHESIVE |
| Product Code | KCO |
| Date Received | 2005-01-07 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | X04193 |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 554262 |
| Manufacturer | GLAXOSMITHKLINE |
| Manufacturer Address | * PARSIPPANY NJ * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-01-07 |