MAUDE Adverse Event Report: PACIRA PHARMACEUTICALS, INC. IOVERA GEN 2; DEVICE, SURGICAL, CRYOGENIC

Catalog Number	IST2221
Medical Device Problem Codes	Energy Output Problem (1431); Temperature Problem (3022)
Health Effect - Clinical Code	Cryogenic Burn (4539)
Date of Event	02/21/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
During the patient's iovera treatment (with gen 2), when hand piece was being used with a new nitrous oxide cartridge, the treatment site got colder than normal and caused the skin to freeze, resulting in freezer burn.The affected area is no larger than a dime, however will result in scabbing.Patient was made aware of this reaction and advised to maintain communication while the treatment site heals.When reported to manufacture rep, it was noted that this was a known issue and was stated to be a "programming issue with the gen 2 device.Should be resolved in next few weeks".

• Brand Name: IOVERA GEN 2
• Common Device Name: DEVICE, SURGICAL, CRYOGENIC
• Manufacturer (Section D): PACIRA PHARMACEUTICALS, INC.; san diego CA 92121
• MDR Report Key: 16447075
• Report Number: MW5115249
• Device Sequence Number: 13840748
• Product Code: GXH
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: IST2221
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/24/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Weight: 53 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White