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 ORIGINAL * manufactured by Glaxosmithkline.
[375903]
This case was reported by a consumer and described the occurrence of uterine hemorrhage in a pt who received poligrip (super poligrip original) 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 diabetes (1994), acid reflux, allergic to glucophage, iodine allergy and iodine dye allergy. Concurrent medications included super poligrip- unidentified, for twenty to thirty years, zyrtec and nexium. In 2002 the pt experienced uterine bleeding related to a benign uterine cyst and had a same day dilation and curettage procedure. Additionally, in 2002 the pt experienced osteoarthritis and treated with same day knee surgery. The events resolved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9681138-2004-00033 |
| MDR Report Key | 559552 |
| Report Source | 04 |
| Date Received | 2004-12-09 |
| Date of Report | 2004-12-08 |
| Date of Event | 2002-01-01 |
| 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 070543884 |
| Manufacturer Country | US |
| Manufacturer Postal | 070543884 |
| Manufacturer Phone | 9738892494 |
| Manufacturer G1 | GLAXOSMITHKLINE, IRELAND |
| Manufacturer Street | YOUGHAL ROAD |
| Manufacturer City | DUNARVIN |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUPER POLIGRIP ORIGINAL |
| 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 | 549255 |
| Manufacturer | GLAXOSMITHKLINE |
| Manufacturer Address | * PARSIPPANY NJ * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-12-09 |