MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-08-28 for IRIX 70 manufactured by Trophy Radioligie.
[16486108]
The reported condition is attributed to a failure of the support arm. This condition was identified by the manufacturer in 1995, and corrective actions were instituted. The device cited in this report is involved in recall.
Patient Sequence No: 1, Text Type: N, H10
[16706091]
Irix scissor arm broke at knuckle. Reported on 6. 18. 08.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8020825-2008-00002 |
| MDR Report Key | 1145595 |
| Report Source | 05 |
| Date Received | 2008-08-28 |
| Date of Report | 2008-07-10 |
| Date of Event | 2008-06-05 |
| Device Manufacturer Date | 1995-09-01 |
| Date Added to Maude | 2009-04-15 |
| 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 CROISSY-BEAUBOURG |
| Manufacturer City | MARNE LA VALLEE 77437 |
| Manufacturer Postal Code | 77437 |
| 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 | 2008-08-28 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TROPHY RADIOLIGIE |
| Manufacturer Address | 4 RUE F. PELLOUTIE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-08-28 |