MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-02-06 for HEUSTIS FILM HOLDER 130 * manufactured by Radiation Products Design Inc..
[253908]
Radiation therapist was placing film holder over patient when film fell onto patient and hit their chest and left eye/cheek. Contustion to left eye/cheek.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 375950 |
| MDR Report Key | 375950 |
| Date Received | 2002-02-06 |
| Date of Report | 2002-02-05 |
| Date of Event | 2002-02-01 |
| Date Facility Aware | 2002-02-04 |
| Report Date | 2002-02-05 |
| Date Reported to FDA | 2002-02-05 |
| Date Reported to Mfgr | 2002-02-05 |
| Date Added to Maude | 2002-02-12 |
| 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 | HEUSTIS FILM HOLDER |
| Generic Name | FILM CASSETTE HOLDING STAND |
| Product Code | EGZ |
| Date Received | 2002-02-06 |
| Model Number | 130 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 20 YR |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 365039 |
| Manufacturer | RADIATION PRODUCTS DESIGN INC. |
| Manufacturer Address | * ALBERTVILLE MN 55301 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2002-02-06 |