• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LEICA BIOSYSTEMS NUSSLOCH LEICA CM1950

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

LEICA BIOSYSTEMS NUSSLOCH LEICA CM1950 Back to Search Results
Model Number 1491950C4US
Device Problem Use of Device Problem (1670)
Patient Problems Laceration(s) (1946); Injury (2348)
Event Date 03/04/2020
Event Type  Injury  
Event Description
On 09 march 2020, leica biosystems received a complaint that a technician cut her finger during cleaning of the microtome cryostat instrument. No further information or confirmation of medical treatment/intervention was provided by the customer site. Leica biosystems made three (3) attempts to confirm if medical treatment/intervention was required for the injured technician; however, no response has been received. If additional information is received a follow up report will be submitted.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameLEICA CM1950
Type of DeviceLEICA CM1950
Manufacturer (Section D)
LEICA BIOSYSTEMS NUSSLOCH
heidelberger strasse 17-19
nussloch, 69226
GM 69226
MDR Report Key9860745
MDR Text Key189329544
Report Number1423337-2020-00004
Device Sequence Number1
Product Code IDP
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/20/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model Number1491950C4US
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/20/2020
Distributor Facility Aware Date03/09/2020
Event Location Hospital
Date Report to Manufacturer03/20/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 03/20/2020 Patient Sequence Number: 1
-
-