MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-07-31 for UROPRO UROLOGY IMAGING SYSTEM NA manufactured by Arcoma Ab.
[14870079]
A pt was being treated in the device when during treatment the x-ray tube arm that supports the x-ray tube and collimator assembly fell on pt resulting in rib fracture. The investigation is still underway but appears to be caused by the mounting screws not being too loose which allowed the x-ray tube arm support to fall.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2082981-2003-00001 |
| MDR Report Key | 475605 |
| Date Received | 2003-07-31 |
| Date of Report | 2003-07-30 |
| Date of Event | 2003-07-25 |
| Date Facility Aware | 2003-07-25 |
| Report Date | 2003-07-30 |
| Date Reported to FDA | 2003-07-30 |
| Date Reported to Mfgr | 2003-07-25 |
| Date Added to Maude | 2003-08-06 |
| Event Key | 0 |
| Report Source Code | Distributor 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 | UROPRO UROLOGY IMAGING SYSTEM |
| Generic Name | UROLOGICAL X-RAY DIAGNOSTIC DEVICE |
| Product Code | ITY |
| Date Received | 2003-07-31 |
| Model Number | UROPRO |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 2 MO |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 464436 |
| Manufacturer | ARCOMA AB |
| Manufacturer Address | ANNAVAGEN 1 VAXJO SW SE-352 46 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2003-07-31 |