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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Decreased Sensitivity (2683)

Event Date 05/10/2019

Event Type  Injury  

Event 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
• Type of Device: DEVICE, SURGICAL, CRYOGENIC
• Manufacturer (Section D): MYOSCIENCE INC./PACIRA PHARMACEUTICALS, INC
• MDR Report Key: 11392022
• MDR Text Key: 234259724
• Report Number: MW5099677
• Device Sequence Number: 1
• Product Code: GXH
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 67 YR
• Patient Weight: 82