MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-08-18 for DEROYAL * C7045 manufactured by Cardinal Health.
[971557]
Opening the gypsona bandage package causes a cloud of plaster dust in the or. Surgery used to purchase a similar 4" x 5yd plaster casting bandage made by debusk but without warning started receiving the gypsona product by bsn medical with the debusk product label on the box covering the gypsona name and product info. The individual product package has just the gypsona name on it.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1199084 |
| MDR Report Key | 1199084 |
| Date Received | 2008-08-18 |
| Date of Report | 2008-08-18 |
| Date of Event | 2008-08-14 |
| Report Date | 2008-08-18 |
| Date Reported to FDA | 2008-08-18 |
| Date Added to Maude | 2008-10-17 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DEROYAL |
| Generic Name | BANDAGE, PLASTER CASTING |
| Product Code | ITG |
| Date Received | 2008-08-18 |
| Model Number | * |
| Catalog Number | C7045 |
| Lot Number | 842338 |
| ID Number | * |
| Operator | NURSE |
| Device Availability | Y |
| Device Age | 6 MO |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 1240280 |
| Manufacturer | CARDINAL HEALTH |
| Manufacturer Address | MEDICAL PRODUCTS AND SERVICES 1430 WAUKEGAN ROAD MCGRAW PARK IL 600856787 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-08-18 |