MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-07-19 for IRIX 70 manufactured by Trophy Radioligie.
[678639]
Irix scissor arm broke at knuckle resulting in approx. 1" laceration to right cheek of pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8020825-2007-00005 |
| MDR Report Key | 883377 |
| Report Source | 05 |
| Date Received | 2007-07-19 |
| Date of Report | 2007-07-18 |
| Date of Event | 2007-06-20 |
| Device Manufacturer Date | 1995-04-01 |
| Date Added to Maude | 2007-09-14 |
| 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 | 0 |
| 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 | 7702263518 |
| Manufacturer G1 | TROPHY RADIOLIGIE |
| Manufacturer Street | 4 RUE F. PELLOUTIE 77437 MARNE LA VALLEE |
| Manufacturer City | CROISSY-BEAUBOURG |
| Manufacturer Country | FR |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IRIX 70 |
| Generic Name | DENTAL X-RAY SYSTEM |
| Product Code | EAP |
| Date Received | 2007-07-19 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 867735 |
| Manufacturer | TROPHY RADIOLIGIE |
| Manufacturer Address | 4 RUE F. PELLOUTIE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-07-19 |