FDA Adverse Event
Injury
Summary report: N
PANORAMIC X-RAY MODEL PC-1000
MDR report key: 4806076
·
Received May 15, 2015
Report
- Report Number
- 1832462-2015-00009
- Event Type
- Injury
- Date Received
- May 15, 2015
- Date of Event
- February 10, 2015
- Report Date
- May 6, 2015
- Manufacturer
- PANORAMIC CORP.
- Product Code
- EHD
- PMA / PMN Number
- K870236
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- DENTIST
Narratives
Additional Manufacturer Narrative · 1
DENTAL OFFICE DID NOT PROVIDE FURTHER DETAILS ON PATIENT. (B)(4).
Description of Event or Problem · 1
A RECALL FOR THIS ISSUE WAS INITIATED ON (B)(6) 2015. A STAFF MEMBER WAS ADJUSTING THE HEIGHT OF THE X-RAY MACHINE WHEN IT SLIPPED AND STRUCK A FEMALE PATIENT. PATIENT TEMPORARILY LOST CONSCIOUSNESS AND HAD MINOR BRUISES. SHE DID NOT GO TO THE HOSPITAL VIA AMBULANCE AND TOLD DR. SHE WOULD GET CHECKED OUT ON HER OWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 317853 | PANORAMIC X-RAY MODEL PC-1000 | PC-1000 | EHD | PANORAMIC CORP. | 800724-1 | 6000 - 13885 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |