FDA Adverse Event
Malfunction
Summary report: N
WHITE PROCESSING CASSETTES
MDR report key: 2441920
·
Received January 11, 2012
Report
- Report Number
- 1419341-2012-00001
- Event Type
- Malfunction
- Date Received
- January 11, 2012
- Date of Event
- December 12, 2011
- Report Date
- December 16, 2011
- Manufacturer
- LEICA BIOSYSTEMS RICHMOND
- Product Code
- IDZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE AFFECTED TISSUE PROCESSING CASSETTE WAS NOT RETURNED TO CONTINUE INVESTIGATION. THERE HAVE BEEN NO OTHER REPORTED INCIDENTS WITH THIS PRODUCT OF THIS NATURE.
Description of Event or Problem · 1
CUSTOMER REPORTED THAT WARPING OF THE TISSUE PROCESSING CASSETTE IS CAUSING LIDS TO COME OFF DURING PROCESSING AND THE CUSTOMER HAS LOST A SPECIMEN AS A RESULT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | WHITE PROCESSING CASSETTES | TISSUE CASSETTE | IDZ | LEICA BIOSYSTEMS RICHMOND | 3850510E | 022211 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |