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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LEICA BIOSYSTEMS NUSSLOCH GMBH LEICA CM3050S

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LEICA BIOSYSTEMS NUSSLOCH GMBH LEICA CM3050S Back to Search Results
Catalog Number 14047033534
Device Problem Use of Device Problem (1670)
Patient Problem Laceration(s) (1946)
Event Date 03/31/2021
Event Type  Injury  
Manufacturer Narrative
The investigation revealed that this incident was user related. Garvan employee (ge) sustained a laceration to the hand on the cryostat blade whilst adjusting the brain block mounted on the object head. The users hand slipped on the brain block causing his hand to come into contact with the blade resulting in a laceration. The laceration did not penetrate through the full thickness of the skin. All movement, sensation, circulation and ligements were intact. The wound was cleaned and then closed with glue. Ge given a tetanus vaccination and took keflex 500 mg the injury was not a result of an instrument malfunction.
 
Event Description
On (b)(6) 2021, leica biosystems received a complaint that a user was injured during routine sectioning on their cryostat, cm3050s. The injured user had to be taken to the emergency room and to clean and close the wound with glue.
 
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Brand NameLEICA CM3050S
Type of DeviceLEICA CM3050S
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 Key12311380
MDR Text Key266168472
Report Number8010478-2021-00009
Device Sequence Number1
Product Code IDP
Combination Product (y/n)N
Reporter Country CodeAS
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 08/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number14047033534
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/16/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/27/2003
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: 08/12/2021 Patient Sequence Number: 1
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