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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LEICA BIOSYSTEMS NUSSLOCH GMBH LEICA CM1860UV

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LEICA BIOSYSTEMS NUSSLOCH GMBH LEICA CM1860UV Back to Search Results
Catalog Number 1491860UVUS
Device Problems Use of Device Problem (1670); Appropriate Term/Code Not Available (3191)
Patient Problem Burn(s) (1757)
Event Date 01/07/2022
Event Type  Injury  
Event Description
On (b)(6) 2022, leica biosystems was contacted by the complainant regarding an incident with the use of flammable freezing spray in their cm1860uv cryostat. The complainant communicated to leica biosystems that their laboratory employee was sent to the emergency room with 1st and 2nd degree burns. This incident is still under investigation and a follow up report will be submitted should additional information become available following the investigation.
 
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Brand NameLEICA CM1860UV
Type of DeviceCM1860UV
Manufacturer (Section D)
LEICA BIOSYSTEMS NUSSLOCH GMBH
heidelbergerstrasse 17-19
nussloch, 69226
GM 69226
MDR Report Key13455415
MDR Text Key289273709
Report Number1423337-2022-00005
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,Followup
Report Date 03/03/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/04/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number1491860UVUS
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/03/2022
Distributor Facility Aware Date01/07/2022
Event Location Hospital
Date Report to Manufacturer03/03/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 02/04/2022 Patient Sequence Number: 1
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