MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-13 for LEICA CM1950 1491950C03JR1601 manufactured by Leica Biosystems Nussloch Gmbh.
[130314327]
The investigation revealed the following: the incident was user related due to a wrong application from the customer site. He did use a pathological tissue quick freezing spray, named white freezer s, which is a flammable substance, and not recommended for use in the leica cm1950, according to the instructions for use. A customer facing letter will be sent to the customer with a recommendation in the future not to use flammable substances in the leica cm1950 when it is turned on and plugged in.
Patient Sequence No: 1, Text Type: N, H10
[130314328]
A customer reported to leica biosystems that on (b)(6) 2018 combustion with fire occurred during the usage of an instant cooling agent on the freezing shelf in their cm1950. On (b)(6) 2018 the customer informed leica biosystems that he was burned on his arm and the hair on his forehead. He was wearing a mask and goggles which prevented him from being burned on his face. Medical treatment was necessary.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010478-2018-00005 |
| MDR Report Key | 8161565 |
| Date Received | 2018-12-13 |
| Date of Report | 2018-11-14 |
| Date of Event | 2018-11-14 |
| Date Mfgr Received | 2018-11-14 |
| Device Manufacturer Date | 2013-02-07 |
| Date Added to Maude | 2018-12-13 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. ROBERT GROPP |
| Manufacturer Street | HEIDELBERGERSTR. 17-19 |
| Manufacturer City | NUSSLOCH, 69226 |
| Manufacturer Country | GM |
| Manufacturer Postal | 69226 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | LEICA CM1950 |
| Generic Name | LEICA CM1950 |
| Product Code | IDP |
| Date Received | 2018-12-13 |
| Model Number | 1491950C03JR1601 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 0 |
| 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 | 2018-12-13 |