MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2006-02-10 for IRIX 70 manufactured by Trophy Radiologie.
[402900]
Notified that irix 70 scissor arm was cracking, then broke.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8020825-2006-00001 |
| MDR Report Key | 677034 |
| Report Source | 05 |
| Date Received | 2006-02-10 |
| Date of Report | 2006-02-03 |
| Date of Event | 2006-01-14 |
| Report Date | 2006-02-02 |
| Device Manufacturer Date | 1995-04-01 |
| Date Added to Maude | 2006-02-21 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | LINDA SPITZER |
| Manufacturer Street | 1765 THE EXCHANGE |
| Manufacturer City | ATLANTA GA 30339 |
| Manufacturer Country | US |
| Manufacturer Postal | 30339 |
| Manufacturer Phone | 6785898673 |
| 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 | IRIX 70 |
| Generic Name | DENTAL X-RAY SYSTEM |
| Product Code | EAP |
| Date Received | 2006-02-10 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 666318 |
| Manufacturer | TROPHY RADIOLOGIE |
| Manufacturer Address | 4 RUE F. PELLOUTIER 77437 MARNE LA VALLEE CROISSY-BEAUBOURG CEDEX 2 FR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-02-10 |