MAUDE Adverse Event Report: MYOSCIENCE INC./PACIRA PHARMACEUTICALS, INC IOVERA; DEVICE, SURGICAL, CRYOGENIC

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hyporesponsive to stimuli (2683)
Date of Event	05/10/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Altered sensation remaining; i had iovera for a knee replacement.I still have not regained normal sensation.Fda safety report id # (b)(4).

• Brand Name: IOVERA
• Common Device Name: DEVICE, SURGICAL, CRYOGENIC
• Manufacturer (Section D): MYOSCIENCE INC./PACIRA PHARMACEUTICALS, INC
• MDR Report Key: 11392022
• Report Number: MW5099677
• Device Sequence Number: 13505512
• Product Code: GXH
• Initial Reporter State: NE
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 02/24/2021

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: No Information
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/26/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 67 YR
• Patient Weight: 82