MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2002-06-17 for RADIATION PRODUCTS DESIGN FILM HOLDER 130-001 manufactured by Radiation Products Design, Inc..
[270454]
Cassette holder broke at the base and could have injured a patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2182762-2002-00001 |
| MDR Report Key | 400436 |
| Report Source | 05,06 |
| Date Received | 2002-06-17 |
| Date Facility Aware | 2002-05-22 |
| Report Date | 2002-06-10 |
| Date Reported to Mfgr | 2002-05-23 |
| Date Mfgr Received | 2002-05-23 |
| Device Manufacturer Date | 1997-10-01 |
| Date Added to Maude | 2002-06-21 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | HOWARD LARSON |
| Manufacturer Street | 5218 BARTHEL INDUSTRIAL DRIVE |
| Manufacturer City | ALBERTVILLE MN 55301 |
| Manufacturer Country | US |
| Manufacturer Postal | 55301 |
| Manufacturer Phone | 7634972071 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RADIATION PRODUCTS DESIGN FILM HOLDER |
| Generic Name | FILM CASSETTE HOLDING DEVICE |
| Product Code | EGZ |
| Date Received | 2002-06-17 |
| Model Number | 130-001 |
| Catalog Number | 130-001 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 1.3 YR |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 389489 |
| Manufacturer | RADIATION PRODUCTS DESIGN, INC. |
| Manufacturer Address | 5218 BARTHEL INDUSTRIAL DR. ALBERTVILLE MN 553019766 US |
| Baseline Brand Name | RADIATION PRODUCTS DESIGN MOBILE CASSETTE HOLDER |
| Baseline Generic Name | MOBILE CASSETTE HOLDER |
| Baseline Model No | 130-001 |
| Baseline Catalog No | 130-001 |
| Baseline ID | NA |
| Baseline Device Family | MOBILE CASSETTE HOLDER |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2002-06-17 |