MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-04-12 for 765DC INTRAORAL X-RAY SYSTEM 110-0154G3 A0765DC75 manufactured by Gendex Imaging.
[20617152]
Assistant lined up the pt with the rinn holder and the arm snapped and hit the pt on the left side of her face. Pt was cut on the face.
Patient Sequence No: 1, Text Type: D, B5
[20826376]
Conclusion: defective scissors arm. Scissor arm and tubehead replaced.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1419798-2007-00012 |
| MDR Report Key | 842004 |
| Report Source | 05 |
| Date Received | 2007-04-12 |
| Date of Report | 2007-04-02 |
| Date of Event | 2007-03-29 |
| Date Mfgr Received | 2007-04-02 |
| Device Manufacturer Date | 2001-05-01 |
| Date Added to Maude | 2007-04-30 |
| 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 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | JOHN MILLER, DIR |
| Manufacturer Street | 901 W OAKTON ST |
| Manufacturer City | DES PLAINES IL 60018 |
| Manufacturer Country | US |
| Manufacturer Postal | 60018 |
| Manufacturer Phone | 8473643931 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 765DC INTRAORAL X-RAY SYSTEM |
| Generic Name | DIAGNOSTIC X-RAY UNIT |
| Product Code | EAP |
| Date Received | 2007-04-12 |
| Model Number | 110-0154G3 |
| Catalog Number | A0765DC75 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 829279 |
| Manufacturer | GENDEX IMAGING |
| Manufacturer Address | 901 W OAKTON ST DES PLAINES IL 60018 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-04-12 |