MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-20 for LEICA CM1850 1491850CE01 manufactured by Leica Biosystems Nussloch Gmbh.
[36420123]
On (b)(6) 2015 while on-site servicing another instrument, a leica biosystems sevice engineer (fse) was notified by the hospital bio-medical engineer that a user cut his finger while using the leica cm1850. Per the user, the injury occurred on (b)(6) 2015. The user was treated for his injury and provided 4 weeks of prophylactic treatment at the (b)(6) medical center due to the nature of the specimens cut with the instrument.
Patient Sequence No: 1, Text Type: D, B5
[39856798]
Leica did not receive a response after several attempts to contact the customer for additional information, therefore the investigation of this incident and complaint have been closed by the manufacturer. A follow up report will be submitted if additional information is provided by the customer. A customer facing letter was generated by the manufacturer and will be provided to the customer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423337-2016-00001 |
| MDR Report Key | 5380398 |
| Date Received | 2016-01-20 |
| Date of Report | 2015-12-22 |
| Date of Event | 2015-12-10 |
| Date Facility Aware | 2015-12-22 |
| Report Date | 2016-03-03 |
| Date Reported to FDA | 2016-03-03 |
| Date Reported to Mfgr | 2016-03-03 |
| Date Added to Maude | 2016-01-20 |
| 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 CM1850 |
| Generic Name | MICROTOME, CRYOSTAT |
| Product Code | IDP |
| Date Received | 2016-01-20 |
| Model Number | 1491850CE01 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LEICA BIOSYSTEMS NUSSLOCH GMBH |
| Manufacturer Address | HEIDELBERGER STRASSE 17-19 NUSSLOCH, 69226 GM 69226 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-01-20 |