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

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.

Event Description

The reporter called to report an adverse event that they associated with the use of frostbite (material number 3803100; 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.

• Brand Name: FROSTBITE
• Type of Device: FROSTBITE, PRODUCT CODE: LEA
• Manufacturer (Section D): LEICA BIOSYSTEMS; 5205 us highway 12; richmond, il IL 32803
• MDR Report Key: 8957915
• MDR Text Key: 161068602
• Report Number: 1419341-2019-00004
• Device Sequence Number: 1
• Product Code: LEA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• 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 Received: 09/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 06/12/2021
• Device Model Number: 3803100
• Device Lot Number: 061221
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other