FDA Adverse Event
Summary report: N
IP BIOPSY CASSETTE II
MDR report key: 2306165
·
Received October 12, 2011
Report
- Report Number
- 2306165
- Date Received
- October 12, 2011
- Date of Event
- August 8, 2011
- Report Date
- October 12, 2011
- Manufacturer
- LEICA BIOSYSTEMS
- Product Code
- KER
- Report Source
- User Facility report
- Reporter Location
- MA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
A TISSUE CASSETTE WAS NOTED TO HAVE NO TISSUE INSIDE. A PIECE OF THE CASSETTE WAS NOTED TO BE MISSING. ALL BIOPSY CASSETTES WILL BE TAKEN OUT OF SERVICE AND TISSUES CASSETTES WITH SPONGES WILL BE USED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IP BIOPSY CASSETTE II | BIOPSY CASSETTES | KER | LEICA BIOSYSTEMS | * | M506TIP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |