FDA Adverse Event
Malfunction
Summary report: N
DIGITAL RADIOGRAPHY CXDI-70C WIRELESS
MDR report key: 2802651
·
Received October 19, 2012
Report
- Report Number
- 1000181430-2012-00052
- Event Type
- Malfunction
- Date Received
- October 19, 2012
- Report Date
- September 13, 2012
- Manufacturer
- CANON, INC.
- Product Code
- MQB
- PMA / PMN Number
- K102012
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). INVESTIGATION IS STILL IN PROGRESS. IF ADDITIONAL INFO IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED PER 21 CFR 803.56. (B)(4).
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT AN IMAGE WAS NOT CAPTURED. IT IS POSSIBLE THAT THE IMAGE WAS RETAKEN, RESULTING IN UNINTENDED RADIATION EXPOSURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DIGITAL RADIOGRAPHY CXDI-70C WIRELESS | MQB | CANON, INC. | CXDI-70C WIRELESS | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |