MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-10-17 for ARRIFLEX ARRITECHNO 35 * manufactured by Arri, Inc.
[341412]
A patient was being prepped for a cardiac cath when the cover of the cine film magazine fell off and struck the pt on the forehead causing a one and half inch scalp laceration. The pt was transported to the er [emergency room] for treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 506914 |
| MDR Report Key | 506914 |
| Date Received | 2003-10-17 |
| Date of Report | 2003-08-01 |
| Date of Event | 2003-04-01 |
| Date Added to Maude | 2004-01-21 |
| 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 | 3 |
| Reporter Occupation | RISK MANAGER |
| 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 | ARRIFLEX |
| Generic Name | CINE CAMERA |
| Product Code | IZJ |
| Date Received | 2003-10-17 |
| Model Number | ARRITECHNO 35 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 495836 |
| Manufacturer | ARRI, INC |
| Manufacturer Address | 617 RT 303 BLAUVELT NY 109131123 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2003-10-17 |