MAUDE Adverse Event Report: ACELITY-3M / KCI USA, INC. VAC VIA; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Lot Number 8647896V005

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Hematoma (1884)

Event Date 07/15/2021

Event Type  Injury  

Event Description

Vac via wound vac failure which resulted exacerbated a hematoma to surgical site.Lot number: 8657896v005.Fda safety report id # (b)(4).

• Brand Name: VAC VIA
• Type of Device: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
• Manufacturer (Section D): ACELITY-3M / KCI USA, INC. ; 3m center ; MN 55144
• MDR Report Key: 12217189
• MDR Text Key: 263394477
• Report Number: MW5102730
• Device Sequence Number: 1
• Product Code: OMP
• 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: 07/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 8647896V005
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 56 YR
• Patient Weight: 82