MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2004-10-01 for POLIGRIP CREAM * manufactured by Glaxosmithkline.
[339815]
This case was reported by a consumer and described the occurrence of stress incontinence from cough in a pt who received poligrip (super poligrip original denture adhesive cream) over a period of two days for loose dentures. A physician or other health care professional has not verified this report. The pt's past medical history included high blood pressure. Concurrent medications included premarin, hyzaar and another high blood pressure pill. In 2004 the pt started poligrip (dental). The pt experienced a violent cough, a choking sensation and subsequently experienced stress incontinence from the cough. Additionally, the pt experienced fullness in their head. This case was assessed as medically serious by gsk. Treatment with poligrip was discontinued. The events resolved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9681138-2004-00019 |
| MDR Report Key | 543429 |
| Report Source | 04 |
| Date Received | 2004-10-01 |
| Date of Report | 2004-09-03 |
| Date of Event | 2004-08-08 |
| Date Mfgr Received | 2004-08-10 |
| Device Manufacturer Date | 2004-02-01 |
| Date Added to Maude | 2004-09-16 |
| 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 | GLAXOSMITHKLINE, IRELAND |
| Manufacturer Street | YOUGHAL RD. |
| Manufacturer City | DUNGARVAN |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POLIGRIP CREAM |
| Generic Name | DENTURE ADHESIVE |
| Product Code | KON |
| Date Received | 2004-10-01 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | X04093 |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 532817 |
| Manufacturer | GLAXOSMITHKLINE |
| Manufacturer Address | * PARSIPPANY NJ * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-10-01 |