FDA Adverse Event
Other
Summary report: N
X-RAY TABLE
MDR report key: 19327
·
Received February 1, 1995
Report
- Report Number
- MW1004954
- Event Type
- Other
- Date Received
- February 1, 1995
- Date of Event
- January 18, 1995
- Report Date
- January 18, 1995
- Manufacturer
- SHIMADZU MEDICAL SYSTEMS
- Product Code
- KXJ
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- LA, US
- Reporter Occupation
- RADIOLOGIC TECHNOLOGIST
Narratives
Description of Event or Problem · 1
DURING EXAMINTION, PT GRABBED END OF TABLE TOP. AS THE MACHINE WAS BEING PLACED IN A MORE ERECT POSITION, TABLE TOP FORWARD MOVEMENT CAUGHT PT'S FINGERS RESULTING IN LACERATION RIGHT 3RD PIP DORSAL, SUTURED AND FRACTURED RIGHT 3RD TUFT DISTAL PHALANX, FINGERGUARD PLACED. HOSP WAS SENT CO'S SERVICE BULLETIN CONCERNING THE NEW HAND GRIP MODIFICATION. SERVICE TECHNICIAN PLACED ORDER FOR HAND GRIP MODIFICATION. RPTR RECOMMENDS THAT MFR SEND THESE TYPES OF ALERTS VIA REGISTERED MAIL TO CUSTOMERS AND THAT MFR EVALUATES POSSIBILITY OF ADDING MYLAR COVERING RIGHT UNDER TABLE-TOP TO SEAL OFF THAT GAP IN THE MACHINE. (*)
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | X-RAY TABLE | X-RAY TABLE | KXJ | SHIMADZU MEDICAL SYSTEMS | RS-110 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Other |