MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-01-11 for WHITE PROCESSING CASSETTES 3850510E manufactured by Leica Biosystems Richmond.
[2420443]
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.
Patient Sequence No: 1, Text Type: D, B5
[9619491]
The affected tissue processing cassette was not returned to continue investigation. There have been no other reported incidents with this product of this nature.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1419341-2012-00001 |
| MDR Report Key | 2441920 |
| Report Source | 05 |
| Date Received | 2012-01-11 |
| Date of Report | 2011-12-16 |
| Date of Event | 2011-12-12 |
| Date Mfgr Received | 2011-12-16 |
| Device Manufacturer Date | 2011-02-01 |
| Date Added to Maude | 2012-08-01 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARI LAMBERT |
| Manufacturer Street | 5205 US ROUTE 12 |
| Manufacturer City | RICHMOND IL 60071 |
| Manufacturer Country | US |
| Manufacturer Postal | 60071 |
| Manufacturer Phone | 8156782000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WHITE PROCESSING CASSETTES |
| Generic Name | TISSUE CASSETTE |
| Product Code | IDZ |
| Date Received | 2012-01-11 |
| Model Number | 3850510E |
| Catalog Number | 3850510E |
| Lot Number | 022211 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LEICA BIOSYSTEMS RICHMOND |
| Manufacturer Address | 5205 US RT 12 RICHMOND IL 60071 US 60071 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-01-11 |