MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-10-12 for IP BIOPSY CASSETTE II * 38440500 manufactured by Leica Biosystems.
[18509066]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2306165 |
| MDR Report Key | 2306165 |
| Date Received | 2011-10-12 |
| Date of Report | 2011-10-12 |
| Date of Event | 2011-08-08 |
| Report Date | 2011-10-12 |
| Date Reported to FDA | 2011-10-12 |
| Date Added to Maude | 2011-10-25 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IP BIOPSY CASSETTE II |
| Generic Name | BIOPSY CASSETTES |
| Product Code | KER |
| Date Received | 2011-10-12 |
| Model Number | * |
| Catalog Number | 38440500 |
| Lot Number | M506TIP |
| ID Number | * |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LEICA BIOSYSTEMS |
| Manufacturer Address | 5205 ROUTE 12 SOLON MILLS IL 60071 US 60071 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-10-12 |