MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2004-11-24 for SUPER WERNET'S * manufactured by Glaxosmithkline, Consumer Healthcare.
[375205]
This case was reported by a consumer and described the occurrence of macular degeneration in a patient who used super wernet's (super wernet's denture adhesive powder) for loose dentures. The consumer contacted the mfr regarding a product inquiry, to praise the product and to make a product complaint. A physician or other health care professional has not verified this report. Concomitant medications include super poligrip denture adhesive powder and super poligrip denture adhesive cream. In approximately 1998, the patient started using super wernet's. In 2001, the patient was diagnosed with macular degeneration. In addition, the patient experienced a cataract in one eye and underwent cataract surgery in 2003. The event of macular degeneration is unresolved. Treatment with the super wernet's is continued.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2650037-2004-00008 |
| MDR Report Key | 556821 |
| Report Source | 04 |
| Date Received | 2004-11-24 |
| Date of Report | 2004-11-18 |
| Date of Event | 2001-01-01 |
| Date Mfgr Received | 2004-10-25 |
| Date Added to Maude | 2004-12-01 |
| 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 | DENTCO FACILITY |
| Manufacturer Street | KILOMETER 76.9 |
| Manufacturer City | HUMACAO PR 00791 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00791 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUPER WERNET'S |
| Generic Name | DENTURE ADHESIVE |
| Product Code | KOP |
| Date Received | 2004-11-24 |
| 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 | 546489 |
| Manufacturer | GLAXOSMITHKLINE, CONSUMER HEALTHCARE |
| Manufacturer Address | * PARSIPPANY NJ * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2004-11-24 |