LEICA CM1850 1491850CE01

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-01-21 for LEICA CM1850 1491850CE01 manufactured by Leica Biosystems Nussloch Gmbh.

Event Text Entries

[36466526] An investigation of the incident is currently ongoing and a follow up including the outcome of the investigation will be submitted.
Patient Sequence No: 1, Text Type: N, H10


[36466527] On (b)(6) 2015 while on-site servicing another instrument, a leica biosystems service engineer (fse) was notified by the hospital bio-med that a user cut their 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) department at (b)(6) center due to the nature of the specimens cut with the instrument.
Patient Sequence No: 1, Text Type: D, B5


[39228552] The customer initially provided a response to the incident; however, because leica did not receive a response after several attempts to contact the customer for additional information, the investigation of this incident and complaint have been closed.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number8010478-2016-00001
MDR Report Key5382425
Report SourceHEALTH PROFESSIONAL
Date Received2016-01-21
Date of Report2015-12-22
Date of Event2015-12-10
Date Mfgr Received2015-12-23
Device Manufacturer Date2006-04-28
Date Added to Maude2016-01-21
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. ROBERT GROPP
Manufacturer StreetHEIDELBERGERSTR. 17-19
Manufacturer CityNUSSLOCH, 69226
Manufacturer CountryGM
Manufacturer Postal69226
Manufacturer Phone6224143345
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameLEICA CM1850
Generic NameMICROTOME, CRYOSTAT, PRODUCT CODE IDP
Product CodeIDP
Date Received2016-01-21
Model Number1491850CE01
OperatorPHYSICIAN
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerLEICA BIOSYSTEMS NUSSLOCH GMBH
Manufacturer AddressHEIDELBERGER STRASSE 17-19 NUSSLOCH, 69226 GM 69226


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2016-01-21

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