MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-05-18 for AQUA BLAST * manufactured by Glaxosmithkline.
[337551]
Glaxosmithkline is apparently not required to list ingredients on aquablast retainer cleaner. Why? Online reporter learned that it contains two ingredients that may cause "severe skin" and/or "eye" irritants.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1032230 |
| MDR Report Key | 531003 |
| Date Received | 2004-05-18 |
| Date of Report | 2004-05-18 |
| Date of Event | 2004-05-05 |
| Date Added to Maude | 2004-06-24 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AQUA BLAST |
| Generic Name | RETAINER CLEANER |
| Product Code | JER |
| Date Received | 2004-05-18 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 520251 |
| Manufacturer | GLAXOSMITHKLINE |
| Manufacturer Address | * * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-05-18 |