MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-07-29 for CONVERTERS ASTOUND * 2024-50 manufactured by Allegiance/cardinal Health.
[22170974]
Gown is defective. Came apart when gown was put on. No injury to pt. Not used in procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1029156 |
| MDR Report Key | 475540 |
| Date Received | 2003-07-29 |
| Date of Report | 2003-07-29 |
| Date of Event | 2003-07-22 |
| Date Added to Maude | 2003-08-06 |
| 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 | 0 |
| Reporter Occupation | RISK MANAGER |
| 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 | CONVERTERS ASTOUND |
| Generic Name | GOWN |
| Product Code | FYB |
| Date Received | 2003-07-29 |
| Model Number | * |
| Catalog Number | 2024-50 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 464381 |
| Manufacturer | ALLEGIANCE/CARDINAL HEALTH |
| Manufacturer Address | 1430 WAUKENGEN RD MCGAW IL 60085 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2003-07-29 |