MAUDE Adverse Event Report: HYALURONIC ACID SYRINGE PEN; PEN INJECTOR

Lot Number 0220210415

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 04/19/2021

Event Type  Injury  

Event Description

Lipo lab ppc solution ((b)(4) product): phosphatidycholine, deoxycholate.Yipner (made in (b)(4)).

• Brand Name: HYALURONIC ACID SYRINGE PEN
• Type of Device: PEN INJECTOR
• MDR Report Key: 12138072
• MDR Text Key: 260877300
• Report Number: MW5102398
• Device Sequence Number: 1
• Product Code: NSC
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 04/14/2021
• Device Lot Number: 0220210415
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 24 YR
• Patient Weight: 66