MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2005-02-07 for POLIGRIP ULTRA FRESH DENTURE ADHESIVE CREAM * manufactured by Glaxosmithkline, Consumer Healthcare.
[22188029]
This case was reported by a consumer and described the occurrence of a gastric obstruction in a pt who used poligrip (super poligrip ultra fresh denture adhesive cream) for loose 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 an elective gastric stapling in 1983. Concurrent medical conditions included acid reflux, allergy to weeds, arthritis and fibromyalgia. Co-suspect medication includes os-cal 500+d tablets, which they have used since 1983. Concurrent medications included wellbutrin, nexium, celexa, lipitor, hctz and premarin. In 1981, the pt started using poligrip (dental). In 2002, the pt experienced an inability to walk, a five to seven pound per week weight loss, a loss of energy and an enlarged liver. They were diagnosed with a stomach occlusion, was subsequently hospitalized and underwent a surgical repair of this occlusion 2002. Treatment with poligrip and os-cal 500+d report was continued. The events are resolved. Mfr's comment: the mfr's report number for this case is 9681138-2005-00002. Super poligrip ultra fresh denture adhesive cream is manufactured in dungarvan ireland and neither the lot number nor the product are available for testing. No corrective actions have been required based on this report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9681138-2005-00002 |
| MDR Report Key | 571320 |
| Report Source | 04 |
| Date Received | 2005-02-07 |
| Date of Report | 2005-02-07 |
| Date of Event | 2002-09-01 |
| Date Mfgr Received | 2005-01-27 |
| Date Added to Maude | 2005-02-10 |
| 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 | POLIGRIP ULTRA FRESH DENTURE ADHESIVE CREAM |
| Generic Name | DENTURE ADHESIVE |
| Product Code | KOP |
| Date Received | 2005-02-07 |
| 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 | 561168 |
| Manufacturer | GLAXOSMITHKLINE, CONSUMER HEALTHCARE |
| Manufacturer Address | * PARSIPPANY NJ * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2005-02-07 |