MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 1999-11-11 for INTRAORAL X-RAY DENTAL SYSTEM IRIX 70 NA manufactured by Trophy Radiologie Div. Of Trex Medical Corp..
[195483]
It was reported that the scissor-arm broke at the casting causing the unit to fall and hit a pt. No injury was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8020825-1999-00050 |
| MDR Report Key | 250190 |
| Report Source | 08 |
| Date Received | 1999-11-11 |
| Date of Report | 1999-11-10 |
| Date of Event | 1999-09-01 |
| Date Mfgr Received | 1999-09-10 |
| Date Added to Maude | 1999-11-19 |
| 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 | PHILIP JUHAS |
| Manufacturer Street | 36 APPLE RIDGE RD |
| Manufacturer City | DANBURY CT 06810 |
| Manufacturer Country | US |
| Manufacturer Postal | 06810 |
| Manufacturer Phone | 2037901188 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | Z-1099/1101-5 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INTRAORAL X-RAY DENTAL SYSTEM |
| Generic Name | RADIOLOGIC |
| Product Code | FAP |
| Date Received | 1999-11-11 |
| Model Number | IRIX 70 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 242388 |
| Manufacturer | TROPHY RADIOLOGIE DIV. OF TREX MEDICAL CORP. |
| Manufacturer Address | 4 RUE F. PELLOUTER CROISSY BEABOURG MARNE LA VALLEE, CEDEX FR 2 |
| Baseline Brand Name | INTRAORAL DENTAL X-RAY SYSTEM 70-X |
| Baseline Generic Name | RADIOLOGIC |
| Baseline Model No | IRIX 70 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1999-11-11 |