MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2008-10-08 for IRIX 70 manufactured by Trophy Radiologie.
[945248]
Irix scissor arm broke at knuckle. Arm fell and struck pt on or about head. Medical attention was obtained. Pt name not disclosed.
Patient Sequence No: 1, Text Type: D, B5
[8198346]
The reported condition is attributed to a failure of the support arm. This condition was identified by the mfr in 1995 and corrective actions were instituted. The device cited in this report is involved in recall z-1099/1101-5.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8020825-2008-00003 |
| MDR Report Key | 1193545 |
| Report Source | 05,08 |
| Date Received | 2008-10-08 |
| Date of Report | 2008-08-10 |
| Date of Event | 2008-07-23 |
| Device Manufacturer Date | 1993-06-01 |
| Date Added to Maude | 2010-04-16 |
| 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 RADIOLOGIE |
| Manufacturer Street | 4 RUE F. PELLOUTIER CROISSY-BEAUBORG |
| Manufacturer City | MARNE LA VALLEE CEDEX 2 77437 |
| Manufacturer Country | FR |
| 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 | 2008-10-08 |
| Returned To Mfg | 2008-07-30 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TROPHY RADIOLOGIE |
| Manufacturer Address | 4 RUE F. PELLOUTIER |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-10-08 |