MAUDE Adverse Event Report: KCI USA INC. V.A.C. THERAPY

Model Number WNDVAC

Device Problems Loss of Power (1475); Device Operates Differently Than Expected (2913)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Event Description

Kci received article, collinge, cory and reddix, robert, the incidence of wound complications related to negative pressure wound therapy power outage and interruption of treatment in orthopaedic trauma patients, journal of orthopaedic trauma.25 (2): 96-100, february 2011.Doi: (b)(6).That reported two patients experienced failed skin grafts that required debridements and new graft placements.The units type of serial numbers were not provided, therefore, kci cannot conduct device evaluations of the units.The co-author/physician confirmed this information was not available.

Manufacturer Narrative

The patients included in this study were treated with negative pressure wound therapy during the may 2008 to nov 2008 time period.It is unknown when the events occurred as this information has not been provided.Based on the information provided, it cannot be determined that the alleged skin graft failures are related to v.A.C.Therapy.The physician reported that v.A.C.Therapy may have caused or contributed to the graft failures stating, "no way to know for sure.".

• Brand Name: V.A.C. THERAPY
• Manufacturer (Section D): KCI USA INC.; san antonio TX
• Manufacturer Contact: paul arrendell ; 6203 farinon drive; san antonio, TX 78249 ; 2105154108
• MDR Report Key: 4023919
• MDR Text Key: 4879858
• Report Number: 3009897021-2014-00111
• 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: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: WNDVAC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/16/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention