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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LEICA BIOSYSTEMS NUSSLOCH GMBH LEICA CM1950

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LEICA BIOSYSTEMS NUSSLOCH GMBH LEICA CM1950 Back to Search Results
Model Number 1491950C4US
Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Injury (2348)
Event Date 03/04/2020
Event Type  Injury  
Manufacturer Narrative
The field service specialist tried three times to contact the customer with no response. No further information or confirmation of medical treatment was provided by the customer.
 
Event Description
On (b)(6) 2020, leica biosystems received a complaint that the customer cut her finger during the cleaning of the microtome cryostat. No further information or confirmation of medical treatment was provided by the customer.
 
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Brand NameLEICA CM1950
Type of DeviceLEICA CM1950
Manufacturer (Section D)
LEICA BIOSYSTEMS NUSSLOCH GMBH
heidelberger strasse 17-19
nussloch, 69226
GM 69226
Manufacturer Contact
robert gropp
heidelbergerstr. 17-19
nussloch, 69226
GM   69226
MDR Report Key9853305
MDR Text Key184321475
Report Number8010478-2020-00005
Device Sequence Number1
Product Code IDP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/19/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number1491950C4US
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/20/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured08/24/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 03/19/2020 Patient Sequence Number: 1
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