MAUDE Adverse Event Report: UNKNOWN SYRINGE; SYRINGE PISTON

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

Patient Problems Pain (1994); Loss of Vision (2139); Excessive Tear Production (2235)

Event Date 03/26/2019

Event Type  Injury  

Event Description

Injection into the eye with avastin for wet macular degeneration.Approximately 30-36 hours later patient experienced severe pain in eye, tearing and no sight.Taken to retina specialist and they confirmed that this was a serious issue.Treated with intravitreal antibiotics and steroid.Culture never grew any bacteria.Patient has never re-gained sight and is severely impacted by this.Other eye has very minimal sight.From further tests and exploratory surgery it has been determined that the optic nerve is dead.Could this be a result of the syringes used by drug companies that were recalled.Fda safety report id # (b)(4).

• Brand Name: SYRINGE
• Type of Device: SYRINGE PISTON
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 8735823
• MDR Text Key: 149468114
• Report Number: MW5087640
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): Y
• 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: 06/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 89 YR
• Patient Weight: 51