FDA Adverse Event
Injury
Summary report: N
MPR
MDR report key: 2581194
·
Received May 10, 2012
Report
- Report Number
- 9613299-2012-00001
- Event Type
- Injury
- Date Received
- May 10, 2012
- Date of Event
- April 13, 2012
- Report Date
- April 13, 2012
- Manufacturer
- GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
- Product Code
- KPS
- PMA / PMN Number
- K951144
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT A NUCLEAR MEDICINE TECHNICIAN SUFFERED FROM A HAND INJURY WHILE PIVOTING THE MPR TABLE OUT OF SCANNING POSITION. THE TECHNICIAN PLACED HER HAND ON THE FRONT EDGE OF THE TABLE IN ORDER TO PUSH IT ASIDE WHILE PREPARING THE SYSTEM FOR COLLIMATOR EXCHANGE PROCEDURE. AS A RESULT, A SHARD OF CARBON FIBER GOT JAMMED INTO THE BASE OF HER PALM. THE TECHNICIAN WENT TO THE HOSPITAL ER FOR TREATMENT AND THE SMALL SPLINTER WAS REMOVED AND THE INJURY AREA REQUIRED STITCHES TO CLOSE THE WOUND. GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MPR | SINGLE PHOTON EMISSION COMPUTED TOMOGRAPHY | KPS | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING | ASM001301 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Other |