MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2003-11-12 for DENOPTIX DIGITAL IMAGING SYSTEM UNK manufactured by Dentsply Gendex.
[22168348]
Surgery was performed on the wrong side of a patient's mouth because a panoramic film cartridge was placed in the imaging unit backwards.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1419870-2003-00197 |
| MDR Report Key | 494845 |
| Report Source | 05,07 |
| Date Received | 2003-11-12 |
| Date of Report | 2003-10-14 |
| Date Added to Maude | 2003-11-14 |
| 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 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | DR PATRICIA KIHN |
| Manufacturer Street | 570 W. COLLEGE AVENUE |
| Manufacturer City | YORK PA 17404 |
| Manufacturer Country | US |
| Manufacturer Postal | 17404 |
| Manufacturer Phone | 7178457511 |
| Manufacturer G1 | DENTSPLY GENDEX |
| Manufacturer Street | 901 W. OAKTON STREET |
| Manufacturer City | DES PLAINES IL 60018 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60018 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DENOPTIX DIGITAL IMAGING SYSTEM |
| Generic Name | AUTOMATIC RADIOGRAPHIC FILM PROCESSOR |
| Product Code | EGY |
| Date Received | 2003-11-12 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 483560 |
| Manufacturer | DENTSPLY GENDEX |
| Manufacturer Address | 901 WEST OAKTON ST. DES PLAINES IL 600181884 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2003-11-12 |