MAUDE Adverse Event Report: WALKMED; 0.22 MICRON FILTER

Lot Number 1404065

Device Problem Insufficient Information (3190)

Patient Problems Dyspnea (1816); Hot Flashes/Flushes (2153); Reaction (2414)

Event Date 07/07/2014

Event Type  Injury  

Event Description

Pt had severe reaction to taxol; flushing, difficulty breathing when 0.22 micron filter was used from (b)(4).Pt had 2 subsequent reactions using 0.22 micron filter from (b)(4).Pt had been previously treated with taxol using a 0.22 micron filter from (b)(4) without reaction.Future tx given with 0.22 micron filter from (b)(4) and no reaction noted.Same rptr as mw5038479, mw5038480, mw5038482, mw5038483, mw5038484.

• Type of Device: 0.22 MICRON FILTER
• Manufacturer (Section D): WALKMED
• MDR Report Key: 4148640
• MDR Text Key: 15998722
• Report Number: MW5038481
• 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: Nurse
• Type of Report: Initial
• Report Date: 09/30/2014
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: 1404065
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Treatment: TAXOL
• Patient Outcome(s): Other
• Patient Age: 56 YR
• Patient Weight: 56