MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2004-09-02 for SUPER WERNET'S (FORMULATION UNKNOWN) * manufactured by Glaxosmithkline.
[20935146]
This case was reported by a consumer and described the occurrence of hernia in a pt who received super wernet's (super wernet's denture adhesive powder) for loose dentures. A physician or other health care professional has not verified this report. The pt's past medical history included foot surgery and high blood pressure. Concurrent medications included unspecified blood pressure medication. Three to five years ago, the pt started super wernet's (dental). In 2003, the pt experienced vomiting and was hospitalized where they were diagnosed with a hernia and treated by surgical repair. Treatment with super wernet's was continued. The events resolved. During the first week in 2004 the pt was diagnosed with coronary artery occlusion during a cardiac catherization and was hospitalized for a stent placement and treatment with clopidogrel bisulphate (plavix). The events resolved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9681138-2004-00020 |
| MDR Report Key | 543266 |
| Report Source | 04 |
| Date Received | 2004-09-02 |
| Date of Report | 2004-08-27 |
| Date Mfgr Received | 2004-08-18 |
| Date Added to Maude | 2004-09-15 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Street | 1500 LITTLETON ROAD |
| Manufacturer City | PARSIPPANY NJ 07054 |
| Manufacturer Country | US |
| Manufacturer Postal | 07054 |
| Manufacturer Phone | 9738892494 |
| Manufacturer G1 | GLAXOSMITHKLINE, IRELAND |
| Manufacturer Street | CLOCHERANE, YOUGHAL ROAD |
| Manufacturer City | DUNGARVIN |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUPER WERNET'S (FORMULATION UNKNOWN) |
| Generic Name | DENTAL ADHESIVE |
| Product Code | KOP |
| Date Received | 2004-09-02 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| 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 | 532641 |
| Manufacturer | GLAXOSMITHKLINE |
| Manufacturer Address | * PARSIPPANY NJ * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2004-09-02 |