MAUDE Adverse Event Report: UNKNOWN SYRINGE

Device Problem Break (1069)

Patient Problems Visual Impairment (2138); Device Embedded In Tissue or Plaque (3165)

Event Date 08/23/2016

Event Type  Injury  

Event Description

I was permanently left with a silicone oil deposit in my eye from the syringe of an avastin injection, for wet macular degeneration.The only way to remove it is surgery.It is now impairing my vision.

• Brand Name: SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 5945925
• MDR Text Key: 54704721
• Report Number: MW5064686
• Device Sequence Number: 1
• Product Code: FMF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/07/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: SYNTHROID
• Patient Age: 55 YR
• Patient Weight: 72