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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); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Burn(s) (1757)
Event Date 01/07/2022
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
A customer reported to leica biosystems on (b)(6) 2022, that they had an incident with a flammable freeze spray in their cm1860uv, cryostat. The employee had to gone to their emergency room with 1st and 2nd degree burns.
 
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Brand NameLEICA CM1860UV
Type of DeviceCM1860UV
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 Key13453182
MDR Text Key285152830
Report Number8010478-2022-00001
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,Followup
Report Date 03/02/2022
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 Catalogue Number1491860UVUS
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Date Manufacturer Received02/15/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/14/2013
Is the Device Single Use? No
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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