MAUDE Adverse Event Report: BAXTER BAXTER FILTER

Device Problem Nonstandard Device (1420)

Patient Problem Inflammation (1932)

Event Date 09/19/2016

Event Type  Injury  

Event Description

Patient had cataract surgery on (b)(6) 2016.Significant, greater than expected eye inflammation diagnosed on (b)(6) 2016.On (b)(6) 2016 leiter's compounding pharmacy recalled medication used on patient lidocaine 1 percent, 1.5 percent phenylephrine preservative free.The recall indicated that the baxter filter recall was the reason for this medication recall.This was one of 5 cataract patients who had tass or inflammation diagnosed who had received the recalled products prepared by the compounding pharmacy.Diagnosis or reason for use: standing order for cataract surgery followed by viscoat.Is the product compounded: yes.Event abated after use stopped or dose reduced: yes.Event reappeared after reintroduction: doesn't apply.All day of surgery (b)(6) 2016.

• Brand Name: BAXTER FILTER
• Type of Device: FILTER
• Manufacturer (Section D): BAXTER
• MDR Report Key: 6010561
• MDR Text Key: 56934631
• Report Number: MW5065232
• Device Sequence Number: 1
• Product Code: FPB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/04/2016

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?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/05/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 64 YR
• Patient Weight: 95