MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2004-09-07 for POLIGRIP CREAM * manufactured by Glaxosmithkline, Consumer Healthcare.
[363771]
This case was reported by a consumer and described the occurrence of breast cancer in a pt who uses poligrip (super poligrip original denture adhesive cream) cream for their dentures. The consumer contacted the mfr regarding a product complaint. A physician or other health care professional has not verified this report. The pt's past medical history included allergy, arthritis and obesity. Concurrent medications included levoxyl, celebrex, chlortrimeton and tylenol. In 2003 the pt started poligrip (dental). In 2003, the pt was diagnosed with right breast cancer. The pt underwent a lumpectomy and one lymph node dissection in 2004 without complications. This case was assessed as medically serious by gsk. The pt was treated with darvocet-n (darvocet). Trreatment with poligrip was continued. The outcome of the event is unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9681138-2004-00021 |
| MDR Report Key | 543499 |
| Report Source | 04 |
| Date Received | 2004-09-07 |
| Date of Report | 2004-09-03 |
| Date of Event | 2003-01-01 |
| Date Mfgr Received | 2004-08-19 |
| 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 | KOP |
| Date Received | 2004-09-07 |
| 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 | 532888 |
| Manufacturer | GLAXOSMITHKLINE, CONSUMER HEALTHCARE |
| Manufacturer Address | * PARSIPPANY NJ * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 1 | 1. Required No Informationntervention | 2004-09-07 |