MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-02 for LEICA CM1520 149491520US manufactured by Leica Biosystems Nussloch Gmbh.
[61399219]
On 08 november 2016, leica biosystems received a user facility medwatch form 3500a from the fda regarding a necessary re-biopsy of one patient. The customer complaint was that the device was chunking into the tissue block during cutting. Upon receipt of this user facility medwatch form 3500a, leica biosystems initially became aware that a re-biopsy was required. For more information please refer to manufacturer report number 8010478-2016-00006.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423337-2016-00030 |
| MDR Report Key | 6142918 |
| Date Received | 2016-12-02 |
| Date of Report | 2016-11-08 |
| Date of Event | 2016-08-03 |
| Date Facility Aware | 2016-11-08 |
| Report Date | 2016-12-02 |
| Date Reported to FDA | 2016-12-02 |
| Date Reported to Mfgr | 2016-12-02 |
| Date Added to Maude | 2016-12-02 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEICA CM1520 |
| Generic Name | CRYOSTAT |
| Product Code | IDP |
| Date Received | 2016-12-02 |
| Model Number | 149491520US |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LEICA BIOSYSTEMS NUSSLOCH GMBH |
| Manufacturer Address | HEIDELBERGERSTR. 17 NUSSLOCH, 69226 GM 69226 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-12-02 |