MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2004-11-03 for IRIX-70 manufactured by Trophy Radiologie.
[22053926]
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 at that time. The device cited in this report is involved in recall.
Patient Sequence No: 1, Text Type: N, H10
[22178394]
Notified in 2004 of a scissor arm breakage at the 1st knuckle.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8020825-2004-00032 |
| MDR Report Key | 874685 |
| Report Source | 05 |
| Date Received | 2004-11-03 |
| Date of Report | 2004-10-28 |
| Date of Event | 2004-10-13 |
| Date Added to Maude | 2007-07-05 |
| 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 | PEGGY BAHT |
| Manufacturer Street | 1765 THE EXCHANGE |
| Manufacturer City | ATLANTA GA 30339 |
| Manufacturer Country | US |
| Manufacturer Postal | 30339 |
| Manufacturer Phone | 6785898556 |
| 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 | 2004-11-03 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 854434 |
| Manufacturer | TROPHY RADIOLOGIE |
| Manufacturer Address | 4 RUE F. PELLOUTIER CROISSY BEAUBOURG MARNE LA VALLEE CEDEX 2 FR 77437 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-11-03 |