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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LEICA BIOSYSTEMS FROSTBITE FROSTBITE, PRODUCT CODE: LEA

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LEICA BIOSYSTEMS FROSTBITE FROSTBITE, PRODUCT CODE: LEA Back to Search Results
Model Number 3803100
Device Problem Environmental Compatibility Problem (2929)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 08/05/2019
Event Type  Injury  
Event Description
The reporter called to report an adverse event that they associated with the use of frostbite (material number 380100; lot number 061221). They reported an allergic reaction when spraying the frostbite into a cryostat. Due to frostbite being in an aerosol can, the product was present in the air when the product was sprayed. The product was not sprayed into the reporter's eyes directly. The symptoms reported included watering and swelling of the eyes, which caused them to have vision trouble. The reporter sought medical attention from an ophthalmologist. The ophthalmologist prescribed steroid drops and an antihistamine for treatment. No further medical attention was required. The reporter noted that the spray can was sprayed inside of a cryostat and the user was not wearing eye protection at the time of the incident. The product label was reviewed. The label does contain a warning for a hazardous material and to consult the safety data sheet (sds) for additional hazards. A review of the sds shows the product requires good ventilation of the work station as well as to wear personal protective equipment. Due to the use of the product as stated, the reporter was using the product off-label. A review of the device history file showed the product passed all quality inspections prior to product release. No further information is available.
 
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Brand NameFROSTBITE
Type of DeviceFROSTBITE, PRODUCT CODE: LEA
Manufacturer (Section D)
LEICA BIOSYSTEMS
5205 us highway 12
richmond, il IL 32803
Manufacturer (Section G)
LEICA BIOSYSTEMS RICHMOND
5205 us highway 12
richmond, il IL 60071
Manufacturer Contact
heather jensen
5205 us highway 12
richmond, il, IL 60071
8156782000
MDR Report Key8957915
MDR Text Key161068602
Report Number1419341-2019-00004
Device Sequence Number1
Product Code LEA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/03/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/12/2021
Device Model Number3803100
Device Lot Number061221
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/19/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/12/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/03/2019 Patient Sequence Number: 1
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