FDA Adverse Event
Injury
Summary report: N
DISPOSA-VIEW
MDR report key: 3167409
·
Received June 11, 2013
Report
- Report Number
- 1718887-2013-00002
- Event Type
- Injury
- Date Received
- June 11, 2013
- Date of Event
- May 1, 2013
- Report Date
- May 20, 2013
- Manufacturer
- VITAL SIGNS COLORADO, INC.
- Product Code
- CCX
- PMA / PMN Number
- EXEMPT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FI
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
UNDER EUROPEAN LAW, PT INFORMATION IS CONSIDERED CONFIDENTIAL AND WILL NOT BE RELEASED BY THE SITE. THE EXACT DATE OF THE REPORTED EVENT IS UNK. GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.
Description of Event or Problem · 1
THE HOSPITAL REPORTED THAT A PT EXPERIENCED UNSPECIFIED "PRESSURE WOUNDS" ON THE CHEEK AND CHIN DURING A PROCEDURE THAT INVOLVED A HEAD POSITIONER. NO FURTHER EVENT OR PT INFORMATION PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 264152 | DISPOSA-VIEW | HEAD POSITIONERS | CCX | VITAL SIGNS COLORADO, INC. | 8000HDP | 20100310 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |