MAUDE Adverse Event Report: KCI USA, INC. PREVENA 125; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Device Problem Device Remains Activated (1525)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Prevena wound dressing was applied appropriately to the incision and the device was running and suction was on the incision but the pump itself would not stop running.Pump was switched out and device still kept running.Provider called and dressing removed from patient.

• Brand Name: PREVENA 125
• Type of Device: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
• Manufacturer (Section D): KCI USA, INC.
• MDR Report Key: 16337605
• MDR Text Key: 309298927
• Report Number: MW5114814
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/06/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 27 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White