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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 1491950C3US
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Laceration(s) (1946); Injury (2348)
Event Date 12/14/2018
Event Type  Injury  
Manufacturer Narrative
An investigation of the incident is currently underway and a follow up will be submitted should additional information become available following the investigation.
 
Event Description
On 20 december 2018, leica biosystems received a complaint that a resident of the lab injured himself/herself's finger on the blade of the leica cryostat instrument. According to the complainant, the resident of the lab received the "standard postexposure prophylaxis" treatment. No further treatment details were provided. If additional information becomes available a follow up report will be submitted.
 
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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 Key8261608
MDR Text Key133562245
Report Number8010478-2019-00001
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
Report Date 01/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/18/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number1491950C3US
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/20/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/19/2015
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: 01/18/2019 Patient Sequence Number: 1
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